Trial Outcomes & Findings for A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China (NCT NCT06173869)
NCT ID: NCT06173869
Last Updated: 2026-02-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
301 participants
Primary outcome timeframe
On day of oocyte retrieval (up to 22 days after start of stimulation)
Results posted on
2026-02-12
Participant Flow
Participant milestones
| Measure |
FE 999049
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
153
|
|
Overall Study
COMPLETED
|
126
|
131
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
Baseline characteristics by cohort
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 3.6 • n=41 Participants
|
32.2 Years
STANDARD_DEVIATION 3.8 • n=1581 Participants
|
32.3 Years
STANDARD_DEVIATION 3.7 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=41 Participants
|
153 Participants
n=1581 Participants
|
301 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=41 Participants
|
153 Participants
n=1581 Participants
|
301 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
148 Participants
n=41 Participants
|
153 Participants
n=1581 Participants
|
301 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
China
|
148 participants
n=41 Participants
|
153 participants
n=1581 Participants
|
301 participants
n=4626 Participants
|
|
Dose Group
Low Starting Dose
|
47 Participants
n=41 Participants
|
51 Participants
n=1581 Participants
|
98 Participants
n=4626 Participants
|
|
Dose Group
High Starting Dose
|
101 Participants
n=41 Participants
|
102 Participants
n=1581 Participants
|
203 Participants
n=4626 Participants
|
|
Body Measurement (Weight)
|
57.5 kg
STANDARD_DEVIATION 8.3 • n=41 Participants
|
57.5 kg
STANDARD_DEVIATION 7.7 • n=1581 Participants
|
57.5 kg
STANDARD_DEVIATION 8.0 • n=4626 Participants
|
PRIMARY outcome
Timeframe: On day of oocyte retrieval (up to 22 days after start of stimulation)Outcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Number of Oocytes Retrieved
|
12.7 Oocytes retrieved
Standard Deviation 5.2
|
11.8 Oocytes retrieved
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)Outcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Number of Follicles on Stimulation Day 6 and End-of-stimulation
Stimulation day 6
|
2.9 Follicles
Standard Deviation 3.0
|
3.0 Follicles
Standard Deviation 3.3
|
|
Number of Follicles on Stimulation Day 6 and End-of-stimulation
End of stimulation
|
13.3 Follicles
Standard Deviation 4.4
|
12.7 Follicles
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)Outcome measures
| Measure |
FE 999049
n=147 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation
Stimulation day 6
|
1303.2 pmol/L
Standard Deviation 1093.1
|
1275.9 pmol/L
Standard Deviation 1050.8
|
|
Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation
End of stimulation
|
11181.2 pmol/L
Standard Deviation 5842.2
|
10124.1 pmol/L
Standard Deviation 4522.2
|
SECONDARY outcome
Timeframe: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)Outcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation
End of Stimulation
|
3.4 nmol/L
Standard Deviation 1.6
|
2.8 nmol/L
Standard Deviation 1.3
|
|
Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation
Stimulation day 6
|
1.6 nmol/L
Standard Deviation 0.9
|
1.4 nmol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)Outcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Number of Fertilised Oocytes
|
7.8 Fertilised Oocytes
Standard Deviation 4.3
|
7.4 Fertilised Oocytes
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)Outcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=151 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Fertilisation Rate
|
59.6 percentage of fertilised oocytes
Standard Deviation 19.9
|
62.7 percentage of fertilised oocytes
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: Day 3 after oocyte retrievalOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Number of Embryos (Total and Quality)
Total
|
8.8 Embryos
Standard Deviation 4.6
|
8.2 Embryos
Standard Deviation 4.6
|
|
Number of Embryos (Total and Quality)
Good-Quality
|
5.5 Embryos
Standard Deviation 3.7
|
5.1 Embryos
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Up to 20 stimulation daysOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Total Gonadotropin Dose
|
154.1 ug
Standard Deviation 41.0
|
167.7 ug
Standard Deviation 48.4
|
SECONDARY outcome
Timeframe: Up to 20 stimulation daysOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Number of Stimulation Days
|
10.6 days
Standard Deviation 1.5
|
10.5 days
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 13-15 days after transferOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Positive βhCG (Positive Serum βhCG Test 13-15 Days After Transfer) Rate
Positive
|
71 Participants
|
72 Participants
|
|
Positive βhCG (Positive Serum βhCG Test 13-15 Days After Transfer) Rate
Negative
|
77 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 5-6 weeks after transferOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Clinical Pregnancy (at Least One Gestational Sac 5-6 Weeks After Transfer) Rate
Positive
|
61 Participants
|
56 Participants
|
|
Clinical Pregnancy (at Least One Gestational Sac 5-6 Weeks After Transfer) Rate
Negative
|
87 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 5-6 weeks after transferOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Vital Pregnancy (at Least One Intrauterine Gestational Sac With Fetal Heart Beat 5-6 Weeks After Transfer) Rate
Positive
|
59 Participants
|
50 Participants
|
|
Vital Pregnancy (at Least One Intrauterine Gestational Sac With Fetal Heart Beat 5-6 Weeks After Transfer) Rate
Negative
|
89 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: 5-6 weeks after transferPopulation: Total Number of gestational sacs (subject level)
The implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.
Outcome measures
| Measure |
FE 999049
n=185 Number of transferred embryos
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=191 Number of transferred embryos
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Implantation Rate
|
40.5 percentage of embryos transferred
|
62 percentage of embryos transferred
|
SECONDARY outcome
Timeframe: 10-11 weeks after transferOutcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Ongoing Pregnancy (at Least One Intrauterine Viable Fetus 10-11 Weeks After Transfer) Rate
Positive
|
54 Participants
|
45 Participants
|
|
Ongoing Pregnancy (at Least One Intrauterine Viable Fetus 10-11 Weeks After Transfer) Rate
Negative
|
94 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: 10-11 weeks after transferPopulation: Low starting dose: 10 μg FE 999049 or 150 IU GONAL-F, high starting dose: 15 μg FE 999049 or 225 IU GONAL-F
The ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by the number of embryos transferred.
Outcome measures
| Measure |
FE 999049
n=185 Number of transferred embryos
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=191 Number of transferred embryos
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Ongoing Implantation Rate (Number of Intrauterine Viable Fetuses 10-11 Weeks After Transfer Divided by Number of Embryos Transferred)
|
36.2 percentage of embryos transferred
|
26.2 percentage of embryos transferred
|
SECONDARY outcome
Timeframe: ≤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)Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. Total OHSS measure the incidence of OHSS both early and late.
Outcome measures
| Measure |
FE 999049
n=148 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 Participants
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)
Early OHSS
|
4 Participants
|
8 Participants
|
|
Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)
Late OHSS
|
2 Participants
|
1 Participants
|
|
Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)
Total OHSS
|
6 Participants
|
9 Participants
|
Adverse Events
FE 999049
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
GONAL-F
Serious events: 11 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FE 999049
n=148 participants at risk
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 participants at risk
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian Hyperstimulation Syndrome
|
0.68%
1/148 • Number of events 1 • 12 months
|
1.3%
2/153 • Number of events 2 • 12 months
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/148 • 12 months
|
0.65%
1/153 • Number of events 1 • 12 months
|
|
Infections and infestations
Dengue Fever
|
0.68%
1/148 • Number of events 1 • 12 months
|
0.00%
0/153 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.68%
1/148 • Number of events 1 • 12 months
|
2.6%
4/153 • Number of events 4 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Threatened
|
0.68%
1/148 • Number of events 1 • 12 months
|
2.0%
3/153 • Number of events 3 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.00%
0/148 • 12 months
|
2.0%
3/153 • Number of events 3 • 12 months
|
Other adverse events
| Measure |
FE 999049
n=148 participants at risk
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg
FE 999049: FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants were treated for a maximum of 20 days.
|
GONAL-F
n=153 participants at risk
The participants received either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU.
GONAL-F: GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose was increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants were treated for a maximum of 20 days.
Coasting was not allowed.
|
|---|---|---|
|
Reproductive system and breast disorders
Hydrometra
|
6.1%
9/148 • Number of events 9 • 12 months
|
4.6%
7/153 • Number of events 8 • 12 months
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
5.4%
8/148 • Number of events 8 • 12 months
|
5.2%
8/153 • Number of events 8 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
9/148 • Number of events 10 • 12 months
|
3.3%
5/153 • Number of events 5 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Biochemical Pregnancy
|
5.4%
8/148 • Number of events 8 • 12 months
|
9.8%
15/153 • Number of events 15 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
5.4%
8/148 • Number of events 8 • 12 months
|
3.3%
5/153 • Number of events 5 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Morning Sickness
|
8.1%
12/148 • Number of events 18 • 12 months
|
6.5%
10/153 • Number of events 15 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place