| Primary | Number of Oocytes Retrieved | The number of oocytes retrieved was recorded at the oocyte retrieval visit. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Oocytes | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00011.1± 5.9
- OG0019.6± 5.5
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Negative binomial regression | Negative binomial regression model with treatment, age strata, and AMH group as factors. | 0.0185 | | Difference | 1.31 | | | 2-Sided | 95 | 0.22 | 2.40 | | | | | Other | | |
|
| Secondary | Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response | For each participant, the reason for cycle cancellation was recorded | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | participants | | At end-of-stimulation (up to 20 days) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) | For each participant, the reason for blastocyst transfer cancellation was recorded. | Participants analyzed for this endpoint represent participants with blastocyst transfer cancellation. | Posted | | Number | | participants | | At end of transfer (up to 4 weeks) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Number of Follicles | The total number of follicles and the number of follicles per size category will be reported | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Number of follicles | | On stimulation day 6 and at end-of-stimulation (up to 20 days) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | Grouped according to number of oocytes | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Number of Metaphase II Oocytes | Only applicable for those inseminated using ICSI | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | MII oocytes | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Fertilization Rate | Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of fertilized oocytes | | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Number of Embryos | The number of embryos (total and good-quality) was reported. Embryo quality is determined by combined assessment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Embryos | | On day 3 after oocyte retrieval (up to 25 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Number of Blastocysts | The number of blastocysts (total and good-quality) was reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is 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) | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Blastocysts | | On day 5 after oocyte retrieval (up to 27 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Circulating Concentrations of Follicle-stimulating Hormone (FSH) | Blood samples for analysis of circulating concentrations of FSH were drawn. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Circulating Concentrations of Luteinizing Hormone (LH) | Blood samples for analysis of circulating concentrations of LH were drawn | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Circulating Concentrations of Estradiol | Blood samples for analysis of circulating concentrations of estradiol were drawn | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | pmol/L | | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Circulating Concentrations of Progesterone | Blood samples for analysis of circulating concentrations of progesterone were drawn | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nmol/L | | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Circulating Concentrations of Inhibin B | Blood samples for analysis of circulating concentrations of Inhibin B were drawn | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | pg/mL | | On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Total Gonadotropin Dose | Calculated by start dates, end dates and daily dose of investigational medicinal product | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ug | | Up to 20 days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Number of Stimulation Days | Calculated by start dates and end dates | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Days | | Up to 20 days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate | Defined as positive serum βhCG test | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | 13-15 days after transfer (up to approximately 1.5 months after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Implantation Rate | Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | Embryos | | 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Clinical Pregnancy Rate | Defined as at least one gestational sac | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Vital Pregnancy Rate | Defined as at least one intrauterine gestational sac with fetal heart beat | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Ongoing Pregnancy Rate | At least one intrauterine viable fetus | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | 10-11 weeks after transfer (up to approximately 4 months after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Ongoing Implantation Rate | Defined as number of intrauterine viable fetuses divided by the number of blastocysts transferred | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | Embryos | | 10-11 weeks after transfer (up to approximately 4 months after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) | Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to 9 days after triggering of final follicular maturation | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) | Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | >9 days after triggering of final follicular maturation | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Frequency of Adverse Events | Any untoward medical occurrence | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From time of signing informed consent until the end-of-trial (approximately 7 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Intensity of Adverse Events | Categorized as mild, moderate or severe | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | From time of signing informed consent until the end-of-trial (approximately 7 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |
| Secondary | Technical Malfunctions of the Pre-filled Injection Pen | Incidences of technical malfunctions of the pre-filled injection pen were recorded | Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to 20 days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 + GnRH Agonist (GONAPEPTYL) | FE 999049 + GnRH agonist (GONAPEPTYL): Pre-filled injection pen | | OG001 | FE 999049 + GnRH Antagonist (CETROTIDE) | FE 999049 + GnRH antagonist (CETROTIDE): Powder and solvent for solution for injection |
| |