| Primary | Number of Fertilized (2 Pronuclei [2PN]) Oocytes | Fertilized oocytes with 2PN were regarded as correctly fertilized. | | Posted | | Mean | Standard Deviation | Fertilized oocytes | | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0008.3± 5.5
- OG0016.7± 4.2
|
|
| |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG. | | Posted | | Count of Participants | | Participants | | 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Clinical Pregnancy Rate | Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound. | | Posted | | Count of Participants | | Participants | | 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Ongoing Pregnancy Rate | Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound | | Posted | | Count of Participants | | Participants | | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Early Pregnancy Loss | Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy. | Only participants who had a positive βhCG test were eligible. | Posted | | Count of Participants | | Participants | | 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Follicular Development on Stimulation Day 6 | The total number of follicles and the number of follicles per size category were reported. | | Posted | | Mean | Standard Deviation | Follicles | | At stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Follicular Development on Last Day of Stimulation | The total number of follicles and the number of follicles per size category were reported. | | Posted | | Mean | Standard Deviation | Follicles | | At last day of stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Serum Follicle-stimulating Hormone (FSH) Concentration | The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | IU/L | | At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Serum Anti-Müllerian Hormone (AMH) Concentration | The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | pmol/L | | At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Human Chorionic Gonadotropin (hCG) Concentration | The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | IU/L | | At Day 6 and last day of stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Luteinizing Hormone (LH) Concentration | The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | IU/L | | At Day 6 and last day of stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Progesterone (P4) Concentration | The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | ng/mL | | At Day 6 and last day of stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Estradiol (E2) Concentration | The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | pg/mL | | At stimulation Day 6 and last day of stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Number of Oocytes Retrieved | The number of oocytes retrieved was recorded at the oocyte retrieval visit. | | Posted | | Mean | Standard Deviation | Oocytes | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Number of Metaphase II (MII) Oocytes | Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other. | Only participants with Oocytes retrieved were eligible. | Posted | | Mean | Standard Deviation | MII Oocytes | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Fertilization Rate | Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved. | Only participants with Oocytes retrieved were eligible. | Posted | | Mean | Standard Deviation | Percentage | | On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval | The number of blastocysts (total and good-quality) was reported. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells) | | Posted | | Mean | Standard Deviation | Blastocysts | | On Day 5 after oocyte retrieval (up to 27 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Total Gonadotropin Dose | The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation. | | Posted | | Mean | Standard Deviation | IU | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Number of Stimulation Days | Calculated by start dates and end dates. | | Posted | | Mean | Standard Deviation | Days | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS) | OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset >9 days after triggering of final follicular maturation. | | Posted | | Number | | Percentage of participants | | ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Frequency of Adverse Events (AEs) | Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint. | | Posted | | Number | | Percentage of participants | | From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Intensity of AEs | The intensity of an AE was classified using the following 3-point scale: Mild = Awareness of signs or symptoms, but no disruption of usual activity. Moderate = Event sufficient to affect usual activity (disturbing). Severe = Inability to work or perform usual activities (unacceptable). | | Posted | | Number | | Percentage of participants | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | umol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mL/min/1.73m2 | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American | Blood samples were collected for the analysis of clinical chemistry parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mL/min/1.73m2 | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
|
| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | RATIO | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cells/uL | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Basophils/leukocytes in Percentage | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cells/uL | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Eosinophils/leukocytes in percentage | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cells/uL | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Lymphocytes/leukocytes in percentage | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cells/uL | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Monocytes/leukocytes in percentage | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | cells/uL | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes | Blood samples were collected for the analysis of haematology parameters. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Neutrophils/leukocytes in percentage | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values. It is only parameters with markedly abnormal values at end of stimulation or end of trial visit which are represented. Parameters with normal baseline values and normal end of stimulation and end of trial values are not represented. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. Participants who were evaluable had normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values. | Posted | | Count of Participants | | Participants | | From the start of screening until the end-of-trial (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | |
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| Secondary | Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period | Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection. Total Number of events include all categories None, Mild, Moderate and Severe. Percentage of events with injection site reactions as a sum of the categories Mild, Moderate and Severe is presented. | | Posted | | Number | | Percentage of events | | Up to 20 stimulation days | Total number of events | Total number of events | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period | Assessed by the participant during the stimulation period as mild, moderate or severe. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection. | | Posted | | Number | | Percentage of events | | Up to 20 stimulation days | Total number of events | Total number of events | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity | Measured by presence of anti-MENOPUR antibodies. 95% Clopper-Pearson confidence interval has been reported in this endpoint. | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to 28 days after end of the stimulation period (simulation period up to 20 days) | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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| Secondary | Number of Participants With Potential Technical Malfunctions of the Administration Pen | Number of participants With Potential Technical malfunctions of the Administration Pen were recorded. | | Posted | | Count of Participants | | Participants | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | MENOPUR Liquid | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration Placebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration | | OG001 | MENOPUR Powder | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. MENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration Placebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration |
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