Trial Outcomes & Findings for A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation (NCT NCT05263388)
NCT ID: NCT05263388
Last Updated: 2025-04-02
Results Overview
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
On day of oocyte retrieval (Up to 22 days after start of stimulation)
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
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.
|
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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|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
|
Overall Study
COMPLETED
|
196
|
94
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Baseline characteristics by cohort
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE is 15 μg fixed for the first four stimulation days. Dose adjustments may be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, can occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose can be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose is 5 μg and the maximum REKOVELLE is 20 μg. Subjects can be treated for a maximum of 20 days.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F is 225 IU fixed for the first four stimulation days. Dose adjustments may be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, can occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose may be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose is 75 IU and the maximum GONAL-F dose is 300 IU. Subjects can be treated for a maximum of 20 days.
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Total
n=300 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
34.5 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Age, Customized
<35 Years
|
83 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age, Customized
35 - 37 Years
|
74 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Customized
38 - 40 Years
|
43 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
173 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
191 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
46 participants
n=5 Participants
|
22 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
35 participants
n=5 Participants
|
15 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=5 Participants
|
13 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
85 participants
n=5 Participants
|
47 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On day of oocyte retrieval (Up to 22 days after start of stimulation)The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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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|---|---|---|
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Number of Oocytes Retrieved
|
9.0 Oocytes Retrieved
Interval 6.0 to 13.5
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9.0 Oocytes Retrieved
Interval 6.5 to 13.0
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SECONDARY outcome
Timeframe: At end-of-stimulation (up to 20 stimulation days)Counted by transvaginal ultrasound for the right and left ovary for each subject.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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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|---|---|---|
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Number of Follicles (Total) at End-of-stimulation
|
12.0 Follicles
Interval 9.0 to 16.0
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12.0 Follicles
Interval 9.0 to 16.0
|
SECONDARY outcome
Timeframe: At end-of-stimulation (up to 20 stimulation days)Counted by ultrasound for the right and left ovary for each subject.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=99 Participants
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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|---|---|---|
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Size of the Follicles at End-of-stimulation
|
15.7 mm
Interval 14.7 to 16.8
|
16.0 mm
Interval 15.1 to 16.9
|
SECONDARY outcome
Timeframe: At end-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of estradiol were drawn.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=197 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=96 Participants
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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|---|---|---|
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Serum Concentrations of Estradiol at End-of-stimulation
|
6085.0 pmol/L
Interval 3516.0 to 8602.0
|
5853.5 pmol/L
Interval 4053.5 to 9742.0
|
SECONDARY outcome
Timeframe: At end-of-stimulation (up to 20 stimulation days)Blood samples for analysis of circulating concentrations of progesterone were drawn.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=197 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=96 Participants
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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|---|---|---|
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Serum Concentrations of Progesterone at End-of-stimulation
|
2.9 nmol/L
Interval 1.9 to 3.8
|
2.5 nmol/L
Interval 1.6 to 3.5
|
SECONDARY outcome
Timeframe: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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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|---|---|---|
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Number of Fertilized Oocytes
|
5.0 Oocytes
Interval 3.0 to 8.0
|
5.0 Oocytes
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=198 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=96 Participants
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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|---|---|---|
|
Fertilization Rate
|
54.5 percentage of oocytes fertilised
Interval 40.0 to 71.4
|
57.7 percentage of oocytes fertilised
Interval 40.0 to 71.4
|
SECONDARY outcome
Timeframe: On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)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.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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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|---|---|---|
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Number of Blastocysts and Number of Good Quality Blastocysts
Number of Blastocysts
|
2.0 Blastocysts
Interval 1.0 to 5.0
|
3.0 Blastocysts
Interval 1.0 to 4.5
|
|
Number of Blastocysts and Number of Good Quality Blastocysts
Number of good quality blastocysts
|
2.0 Blastocysts
Interval 1.0 to 4.0
|
2.0 Blastocysts
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Up to 20 stimulation daysCalculated by start dates, end dates and daily dose of investigational medicinal product (IMP).
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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.
|
|---|---|---|
|
Total Gonadotropin Dose
|
135 ug
Interval 120.0 to 160.0
|
148.5 ug
Interval 137.5 to 165.0
|
SECONDARY outcome
Timeframe: Up to 20 stimulation daysCalculated by start dates and end dates.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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.
|
|---|---|---|
|
Number of Stimulation Days
|
9.0 days
Interval 8.0 to 10.0
|
9.0 days
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 9 days after triggering of final follicular maturationEarly 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.
Outcome measures
| Measure |
REKOVELLE (Follitropin Delta)
n=200 Participants
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.
|
GONAL-F (Follitropin Alfa)
n=100 Participants
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.
|
|---|---|---|
|
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (moderate/severe) and / or preventative interventions
|
30 Participants
|
16 Participants
|
|
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (any grade)
|
5 Participants
|
3 Participants
|
|
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (moderate/severe)
|
1 Participants
|
1 Participants
|
|
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS
Early OHSS (any grade) and / or preventative interventions
|
33 Participants
|
17 Participants
|
Adverse Events
REKOVELLE (Follitropin Delta)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
GONAL-F (Follitropin Alfa)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
REKOVELLE (Follitropin Delta)
n=200 participants at risk
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.
|
GONAL-F (Follitropin Alfa)
n=100 participants at risk
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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Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/200 • 4 months
|
2.0%
2/100 • Number of events 2 • 4 months
|
Other adverse events
| Measure |
REKOVELLE (Follitropin Delta)
n=200 participants at risk
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.
|
GONAL-F (Follitropin Alfa)
n=100 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.5%
23/200 • Number of events 27 • 4 months
|
8.0%
8/100 • Number of events 12 • 4 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.50%
1/200 • Number of events 1 • 4 months
|
5.0%
5/100 • Number of events 5 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place