Trial Outcomes & Findings for Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment (NCT NCT03088137)
NCT ID: NCT03088137
Last Updated: 2022-04-01
Results Overview
The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
From date of randomization up to 18 days
Results posted on
2022-04-01
Participant Flow
Subjects were screened and enrolled at 3 In Vitro Fertilisation (IVF) centers in Russian Federation from 08.02.2017 - 17.08.2018.
Of 118 participants: 8 were reported as screening failures prior the group assignment.
Participant milestones
| Measure |
Primapur (Follitropin Alfa)
Follitropin alfa (Primapur): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
Follitropin alfa (Gonal-f): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Baseline characteristics by cohort
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 2.68 • n=99 Participants
|
30.0 years
STANDARD_DEVIATION 2.71 • n=107 Participants
|
30.65 years
STANDARD_DEVIATION 2.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
55 participants
n=99 Participants
|
55 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
22.0 kg/m2
STANDARD_DEVIATION 2.69 • n=99 Participants
|
22.3 kg/m2
STANDARD_DEVIATION 3.06 • n=107 Participants
|
22.15 kg/m2
STANDARD_DEVIATION 2.87 • n=206 Participants
|
|
Duration of infertility
|
46.4 month
STANDARD_DEVIATION 32.4 • n=99 Participants
|
36.9 month
STANDARD_DEVIATION 26.6 • n=107 Participants
|
41.65 month
STANDARD_DEVIATION 28.22 • n=206 Participants
|
|
Antral follicle
|
11.2 Number of antral follicles
STANDARD_DEVIATION 3.2 • n=99 Participants
|
12.4 Number of antral follicles
STANDARD_DEVIATION 2.4 • n=107 Participants
|
11.80 Number of antral follicles
STANDARD_DEVIATION 2.87 • n=206 Participants
|
|
Anti-mullerian hormone (AMH)
|
4.57 ng per ml
STANDARD_DEVIATION 2.96 • n=99 Participants
|
5.47 ng per ml
STANDARD_DEVIATION 3.82 • n=107 Participants
|
5.02 ng per ml
STANDARD_DEVIATION 3.43 • n=206 Participants
|
|
Follicle stimulating hormone (FSH)
|
6.46 IU/l
STANDARD_DEVIATION 1.86 • n=99 Participants
|
6.76 IU/l
STANDARD_DEVIATION 1.89 • n=107 Participants
|
6.61 IU/l
STANDARD_DEVIATION 1.87 • n=206 Participants
|
|
Estradiol
|
35.87 pg/ml
STANDARD_DEVIATION 12.67 • n=99 Participants
|
33.82 pg/ml
STANDARD_DEVIATION 12.45 • n=107 Participants
|
34.85 pg/ml
STANDARD_DEVIATION 12.54 • n=206 Participants
|
|
Cause of infertility
Tubal factor
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Cause of infertility
Male factor
|
21 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Cause of infertility
Tubal and male factors
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of randomization up to 18 daysPopulation: Intention-to-Treat
The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Oocytes (Intention-to-Treat, ITT)
|
12.16 Number of retrieved oocytes
Standard Deviation 7.28
|
11.62 Number of retrieved oocytes
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: From date of randomization up to 16 daysPopulation: Intention-to-Treat
The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Number of Follicles With Size ≥ 16 mm
|
12.09 Number of follicles
Standard Deviation 6.159
|
11.38 Number of follicles
Standard Deviation 4.965
|
SECONDARY outcome
Timeframe: From date of randomization up to 18 daysPopulation: Intention-to-Treat
The number of mature oocytes (MII stage of development)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Mature Oocytes
|
9.64 Number of mature oocytes (MII stage)
Standard Deviation 6.270
|
9.86 Number of mature oocytes (MII stage)
Standard Deviation 5.546
|
SECONDARY outcome
Timeframe: From date of randomization up to 19 daysPopulation: Intention-to-Treat
The number of fertilised oocytes with the presence of two pronuclei: 2PN
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Fertilised Oocytes
|
8.127 Number of oocytes with 2PN
Standard Deviation 6.608
|
8.764 Number of oocytes with 2PN
Standard Deviation 5.850
|
SECONDARY outcome
Timeframe: From date of randomization up to 25 daysPopulation: Per Protocol
The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=49 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=49 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Percentage of Patients With Embryo Transfer
Embryo transfer on day 3 (%)
|
11 Participants
|
9 Participants
|
|
Percentage of Patients With Embryo Transfer
Embryo transfer on day 5 (%)
|
38 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From date of randomization up to 16 daysPopulation: Intention-to-Treat
The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Total Dose of Follitropin Alfa
|
1532.7 Total dose (IU)
Standard Deviation 267.2
|
1517.9 Total dose (IU)
Standard Deviation 255.2
|
SECONDARY outcome
Timeframe: From date of randomization up to 16 daysPopulation: Intention-to-Treat
The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Number of Days of Follitropin Alfa Treatment
|
9.745 Days
Standard Deviation 1.075
|
9.727 Days
Standard Deviation 1.027
|
SECONDARY outcome
Timeframe: From date of randomization up to 16 daysPopulation: Intention-to-Treat
The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Number of Patients With Follitropin Alfa Dose Correction
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From date of randomization up to 16 daysPopulation: Intention-to-Treat
The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Number of Patients With Cycle Cancellation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization up to 8 daysPopulation: Intention-to-Treat
The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Number of No-responders
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization up to 42 daysPopulation: Per Protocol
Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=49 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=49 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Percentage of Patients With Serum hCG More Than 25 IU/l
|
34.7 Percentage of patients (%)
Interval 21.4 to 48.0
|
36.7 Percentage of patients (%)
Interval 23.2 to 50.2
|
SECONDARY outcome
Timeframe: The 10th week after embryo transferPopulation: Per Protocol
Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Outcome measures
| Measure |
Primapur (Follitropin Alfa)
n=49 Participants
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=49 Participants
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Percentage of Patients With the Evidence for Clinical Pregnancy
|
26.5 Percentage of patients (%)
Interval 14.1 to 38.9
|
32.7 Percentage of patients (%)
Interval 19.6 to 45.8
|
Adverse Events
Primapur (Follitropin Alfa)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Gonal-f (Follitropin Alfa)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primapur (Follitropin Alfa)
n=55 participants at risk
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 participants at risk
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian hyperstymulation syndrome
|
0.00%
0/55 • 1 year, 6 month
|
3.6%
2/55 • Number of events 2 • 1 year, 6 month
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Pregnancy, puerperium and perinatal conditions
Threatened miscarriage
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
Other adverse events
| Measure |
Primapur (Follitropin Alfa)
n=55 participants at risk
Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
Gonal-f (Follitropin Alfa)
n=55 participants at risk
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous miscarriage
|
0.00%
0/55 • 1 year, 6 month
|
3.6%
2/55 • Number of events 2 • 1 year, 6 month
|
|
Pregnancy, puerperium and perinatal conditions
Early Toxicosis During Pregnancy
|
0.00%
0/55 • 1 year, 6 month
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
|
Pregnancy, puerperium and perinatal conditions
Abnormal vaginal bleeding
|
0.00%
0/55 • 1 year, 6 month
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Menses
|
0.00%
0/55 • 1 year, 6 month
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
7.3%
4/55 • Number of events 4 • 1 year, 6 month
|
3.6%
2/55 • Number of events 2 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Decrease in breast sensitivity
|
3.6%
2/55 • Number of events 2 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Pregnancy, puerperium and perinatal conditions
Spotting
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
|
Pregnancy, puerperium and perinatal conditions
Lower abdominal pain
|
3.6%
2/55 • Number of events 2 • 1 year, 6 month
|
7.3%
4/55 • Number of events 4 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Lower abdominal pain
|
5.5%
3/55 • Number of events 3 • 1 year, 6 month
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Pains in the lower abdomen
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Investigations
Laboratory investigations
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Cardiac disorders
Sternum pain
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Cardiac disorders
Palpitations
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Nervous system disorders
Drowsiness
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Abnormal vaginal bleeding
|
5.5%
3/55 • Number of events 3 • 1 year, 6 month
|
1.8%
1/55 • Number of events 1 • 1 year, 6 month
|
|
Reproductive system and breast disorders
Spotting
|
3.6%
2/55 • Number of events 2 • 1 year, 6 month
|
0.00%
0/55 • 1 year, 6 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place