Trial Outcomes & Findings for Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment (NCT NCT01121666)
NCT ID: NCT01121666
Last Updated: 2016-04-15
Results Overview
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
460 participants
Primary outcome timeframe
34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Results posted on
2016-04-15
Participant Flow
Subjects were screened and enrolled at 15 centers in six European countries from July 2010 until April 2012.
Of 460 participants in this trial 88 were reported as screening failures prior the group assignment.
Participant milestones
| Measure |
AFOLIA-150 (Follitropin Alfa)
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
123
|
|
Overall Study
COMPLETED
|
220
|
113
|
|
Overall Study
NOT COMPLETED
|
29
|
10
|
Reasons for withdrawal
| Measure |
AFOLIA-150 (Follitropin Alfa)
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Overall Study
Protocol Violation
|
29
|
10
|
Baseline Characteristics
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
Baseline characteristics by cohort
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 4.02 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 3.76 • n=7 Participants
|
31.95 years
STANDARD_DEVIATION 3.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
229 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
346 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
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
88 participants
n=5 Participants
|
43 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
75 participants
n=5 Participants
|
37 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
33 participants
n=5 Participants
|
19 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
11 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
10 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
FSH baseline concentration
|
6.9 (IU/L)
n=5 Participants
|
6.9 (IU/L)
n=7 Participants
|
6.9 (IU/L)
n=5 Participants
|
|
Antral follicle count
|
15.1 Antral follicle count
n=5 Participants
|
15.3 Antral follicle count
n=7 Participants
|
15.2 Antral follicle count
n=5 Participants
|
|
Body Mass Index
|
22.7 kilogramm/ square meter
n=5 Participants
|
22.4 kilogramm/ square meter
n=7 Participants
|
22.6 kilogramm/ square meter
n=5 Participants
|
|
GnRH-agonist duration
|
23.5 days
n=5 Participants
|
22.7 days
n=7 Participants
|
23.1 days
n=5 Participants
|
|
AMH less than 24 pmol/L
|
106 Number of participants
n=5 Participants
|
47 Number of participants
n=7 Participants
|
153 Number of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatmentPopulation: Per protocol population
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=220 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=113 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number of Oocytes Retrieved (Per Protocol Population)
|
10.8 Number of retrieved oocytes
Standard Deviation 5.11
|
10.6 Number of retrieved oocytes
Standard Deviation 6.06
|
PRIMARY outcome
Timeframe: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatmentPopulation: Intention-to-treat population
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number of Oocytes Retrieved (Intention-to-treat Population)
|
10.7 Number of retrieved oocytes
Standard Deviation 5.62
|
10.4 Number of retrieved oocytes
Standard Deviation 6.14
|
SECONDARY outcome
Timeframe: Day 8 of stimulationPopulation: All participants were analyzed.
The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
≥ 12 mm
|
11.8 Number of follicles
Standard Deviation 4.73
|
11.1 Number of follicles
Standard Deviation 4.23
|
|
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
≥ 15 mm
|
8.3 Number of follicles
Standard Deviation 3.81
|
7.7 Number of follicles
Standard Deviation 3.60
|
|
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
≥ 17 mm
|
4.9 Number of follicles
Standard Deviation 3.29
|
4.5 Number of follicles
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)Population: All participants were analyzed.
The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
E2 Concentration at Day 8 and at Day of hCG Administration
Day of hCG administration
|
8982.3 pmol/ L
Standard Deviation 6535.3
|
7704.2 pmol/ L
Standard Deviation 5345.8
|
|
E2 Concentration at Day 8 and at Day of hCG Administration
Day 8
|
3958.9 pmol/ L
Standard Deviation 3699.4
|
3234.0 pmol/ L
Standard Deviation 2428.1
|
SECONDARY outcome
Timeframe: Day of hCG administration (after maximum 16 days of r-hFSH treatment)Population: All participants were analyzed.
Total dose of r-hFSH required was assessed.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Total Dose of r-hFSH Administered
|
1555.7 IU
Standard Deviation 293.00
|
1569.2 IU
Standard Deviation 259.20
|
SECONDARY outcome
Timeframe: 34-36 hours after hCG administrationPopulation: Intention to treat population
Number of patients with ovum pick-up
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Quality of Oocytes Retrieved
day 2
|
82 Participants
|
36 Participants
|
|
Quality of Oocytes Retrieved
day 3
|
53 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 1 day after ovum pick-upPopulation: Intention to treat population
Fertilisation rate was assessed
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Fertilisation Rate of Oocytes
|
66.1 percentage of oocytes
Standard Deviation 24.84
|
64.0 percentage of oocytes
Standard Deviation 24.76
|
SECONDARY outcome
Timeframe: Day 2 of OPU/fertilisationPopulation: Intention to treat population
Main embryo quality parameter "mean number of blastomeres"
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Embryo Quality: Mean Number of Blastomeres
|
6.6 Number of blastomeres at day 3
Standard Deviation 2.41
|
6.4 Number of blastomeres at day 3
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: Day 1, 2, 3 and 5 of OPU/fertilisationPopulation: Intention to treat population
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts
|
103 Patients with cryopreservation
|
55 Patients with cryopreservation
|
SECONDARY outcome
Timeframe: At the day of hCG administration, up to 16 daysPopulation: All participants were analyzed.
Mean duration of stimulation was assessed.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number of Days of r-hFSH Stimulation
|
10.6 days
Standard Deviation 1.91
|
10.7 days
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Until child birth/miscarriage, up to the end of the studyPopulation: Intention to treat population
Number of patients with cycle cancellation was assessed.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number of Patients With Cycle Cancellation
|
13 Number of patients
|
5 Number of patients
|
SECONDARY outcome
Timeframe: Until child birth/miscarriage, up to the end of the studyPopulation: Intention to treat population.
Good response was defined as "patients with an oocyte retrieval of four or more oocytes"
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Number of Patients With Good Response
|
217 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: Five to six weeks after oocyte retrievalPopulation: Intention to treat population.
Defined as fetal sac per embryo transferred.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Implantation Rate
|
31.8 Percentage of implantations
|
36.7 Percentage of implantations
|
SECONDARY outcome
Timeframe: Five to six weeks after oocyte retrievalPopulation: Intention to treat population
Presence of at least one intrauterine gestational sac.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Clinical Pregnancy Rate
|
90 Clinical pregnancies
|
55 Clinical pregnancies
|
SECONDARY outcome
Timeframe: Ten weeks after embryo transferPopulation: Intention to treat population
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Ongoing Pregnancy
|
84 Ongoing pregnancies
|
51 Ongoing pregnancies
|
SECONDARY outcome
Timeframe: After childbirth with questionnairePopulation: Intention to treat population
Patients with liveborn children
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Live Birth Rate
|
80 Patients with liveborn children
|
51 Patients with liveborn children
|
SECONDARY outcome
Timeframe: Day 3Population: Intention to treat population
Main embryo quality parameter "absence of multinucleation" observed.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Embryo Quality: Absence of Multinucleation
|
93.6 Percentage of absent multinucleation
|
93.9 Percentage of absent multinucleation
|
SECONDARY outcome
Timeframe: At day 4 and 5Population: Intention to treat population
Number of patients with transferred blastocysts
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Quality of Oocytes Retrieved
day 4
|
10 Participants
|
2 Participants
|
|
Quality of Oocytes Retrieved
day 5
|
76 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Day of embryo transfer, either 2, 3 or 5 days after oocyte retrievalPopulation: Intention to treat population
Number of embryos per blastocysts transferred
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Quality of Oocytes Retrieved
|
1.5 embryos per blastocysts transferred
Standard Deviation 0.52
|
1.6 embryos per blastocysts transferred
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Five to six weeks after oocyte retrievalPopulation: Population with a second treatment cycle
Presence of at least one intrauterine gestational sac.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=72 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=38 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Clinical Pregnancy Rate (Second Treatment Cycle)
|
25 Clinical pregnancies
|
10 Clinical pregnancies
|
SECONDARY outcome
Timeframe: 10 weeks after embryo transferPopulation: Population with a second treatment cycle
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=72 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=38 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Ongoing Pregnancy (Second Treatment Cycle)
|
22 Ongoing pregnancies
|
9 Ongoing pregnancies
|
SECONDARY outcome
Timeframe: After oocyte retrieval, 34 to 36 hours after hCG administrationPopulation: Intention to treat population
The maturity of the cumulus oophorus was assessed.
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Quality of Oocytes Retrieved
mature
|
75.7 Percentage of cumulus oophori
|
75.3 Percentage of cumulus oophori
|
|
Quality of Oocytes Retrieved
very mature
|
9.1 Percentage of cumulus oophori
|
9.4 Percentage of cumulus oophori
|
|
Quality of Oocytes Retrieved
immature
|
14.5 Percentage of cumulus oophori
|
14.2 Percentage of cumulus oophori
|
SECONDARY outcome
Timeframe: After oocyte retrieval, 34 to 36 hours after hCG administrationPopulation: Intention to treat population
The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).
Outcome measures
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 Participants
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Quality of Oocytes Retrieved
Germinal vesicle
|
9.5 Percentage of cells
|
9.1 Percentage of cells
|
|
Quality of Oocytes Retrieved
Metaphase I
|
7.2 Percentage of cells
|
7.7 Percentage of cells
|
|
Quality of Oocytes Retrieved
Metaphase II
|
83.4 Percentage of cells
|
83.3 Percentage of cells
|
Adverse Events
AFOLIA-150 (Follitropin Alfa)
Serious events: 12 serious events
Other events: 182 other events
Deaths: 0 deaths
Gonal-f® (Follitropin Alfa)
Serious events: 3 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 participants at risk
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 participants at risk
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
2/249 • Study period + 30 days
|
0.00%
0/123 • Study period + 30 days
|
|
Hepatobiliary disorders
Biliary colic
|
0.40%
1/249 • Study period + 30 days
|
0.00%
0/123 • Study period + 30 days
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.40%
1/249 • Study period + 30 days
|
0.00%
0/123 • Study period + 30 days
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
2.8%
7/249 • Study period + 30 days
|
1.6%
2/123 • Study period + 30 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/249 • Study period + 30 days
|
0.81%
1/123 • Study period + 30 days
|
|
Investigations
Body temparature increased
|
0.40%
1/249 • Study period + 30 days
|
0.00%
0/123 • Study period + 30 days
|
Other adverse events
| Measure |
AFOLIA-150 (Follitropin Alfa)
n=249 participants at risk
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
Gonal-f® (Follitropin Alfa)
n=123 participants at risk
Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
|
|---|---|---|
|
General disorders
Injection site erythema
|
27.3%
68/249 • Study period + 30 days
|
35.8%
44/123 • Study period + 30 days
|
|
General disorders
Injection site haematoma
|
24.1%
60/249 • Study period + 30 days
|
15.4%
19/123 • Study period + 30 days
|
|
Nervous system disorders
Headache
|
22.1%
55/249 • Study period + 30 days
|
20.3%
25/123 • Study period + 30 days
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
22.1%
55/249 • Study period + 30 days
|
13.0%
16/123 • Study period + 30 days
|
|
General disorders
Injection site pain
|
15.7%
39/249 • Study period + 30 days
|
17.1%
21/123 • Study period + 30 days
|
|
Gastrointestinal disorders
Nausea
|
9.2%
23/249 • Study period + 30 days
|
4.9%
6/123 • Study period + 30 days
|
|
General disorders
Injection site swelling
|
6.0%
15/249 • Study period + 30 days
|
8.1%
10/123 • Study period + 30 days
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
14/249 • Study period + 30 days
|
4.9%
6/123 • Study period + 30 days
|
|
General disorders
Fatigue
|
5.2%
13/249 • Study period + 30 days
|
3.3%
4/123 • Study period + 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
13/249 • Study period + 30 days
|
4.9%
6/123 • Study period + 30 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
7/249 • Study period + 30 days
|
5.7%
7/123 • Study period + 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place