| Primary | Number of Oocytes Retrieved | The number of oocytes retrieved was recorded at the oocyte retrieval visit. | | Posted | | Median | Inter-Quartile Range | Oocytes Retrieved | | On day of oocyte retrieval (Up to 22 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0009.0(6.0 to 13.5)
- OG0019.0(6.5 to 13.0)
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| Secondary | Number of Follicles (Total) at End-of-stimulation | Counted by transvaginal ultrasound for the right and left ovary for each subject. | | Posted | | Median | Inter-Quartile Range | Follicles | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Size of the Follicles at End-of-stimulation | Counted by ultrasound for the right and left ovary for each subject. | | Posted | | Median | Inter-Quartile Range | mm | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Serum Concentrations of Estradiol at End-of-stimulation | Blood samples for analysis of circulating concentrations of estradiol were drawn. | | Posted | | Median | Inter-Quartile Range | pmol/L | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Serum Concentrations of Progesterone at End-of-stimulation | Blood samples for analysis of circulating concentrations of progesterone were drawn. | | Posted | | Median | Inter-Quartile Range | nmol/L | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Number of Fertilized Oocytes | The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized. | | Posted | | Median | Inter-Quartile Range | Oocytes | | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Fertilization Rate | The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved. | | Posted | | Median | Inter-Quartile Range | percentage of oocytes fertilised | | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Number of Blastocysts and Number of Good Quality Blastocysts | Number of blastocysts and number of good quality blastocysts on Day 5 or 6 were presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner & Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher. | | Posted | | Median | Inter-Quartile Range | Blastocysts | | On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Total Gonadotropin Dose | Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP). | | Posted | | Median | Inter-Quartile Range | ug | | Up to 20 stimulation days | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Number of Stimulation Days | Calculated by start dates and end dates. | | Posted | | Median | Inter-Quartile Range | days | | Up to 20 stimulation days | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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| Secondary | Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS | Early OHSS is defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. | | Posted | | Count of Participants | | Participants | | Up to 9 days after triggering of final follicular maturation | | | | ID | Title | Description |
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| OG000 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. |
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