Trial Outcomes & Findings for Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI. (NCT NCT00335725)
NCT ID: NCT00335725
Last Updated: 2015-03-27
Results Overview
Total number of oocytes retrieved
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
151 participants
Primary outcome timeframe
10 days after stimulation start
Results posted on
2015-03-27
Participant Flow
Participant milestones
| Measure |
Fostimon
Highly purified FSH
|
Gonal-f
Recombinant FSH
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
76
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Baseline characteristics by cohort
| Measure |
Fostimon
n=75 Participants
|
Gonal-f
n=76 Participants
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
basal FSH
|
5.9 IU/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
6.0 IU/L
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.0 IU/L
STANDARD_DEVIATION 2.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 days after stimulation startPopulation: patients who started the stimulation with FSH
Total number of oocytes retrieved
Outcome measures
| Measure |
Fostimon
n=73 Participants
|
Gonal-f
n=72 Participants
|
|---|---|---|
|
Total Number of Oocytes Retrieved
|
10.9 oocytes
Standard Deviation 4.9
|
12.0 oocytes
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 6 weeks after treatment startPopulation: patients who started the FSH treatment
clinical pregnancy rate defined as the presence of gestation sac and heart beat.
Outcome measures
| Measure |
Fostimon
n=73 Participants
|
Gonal-f
n=72 Participants
|
|---|---|---|
|
Clinical Pregnancy Rate
|
30.1 percentage of treated patients
|
29.2 percentage of treated patients
|
Adverse Events
Fostimon
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Gonal-F
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fostimon
n=73 participants at risk
|
Gonal-F
n=72 participants at risk
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
OHSS
|
1.4%
1/73 • Number of events 1
|
5.6%
4/72 • Number of events 4
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.4%
1/73 • Number of events 1
|
0.00%
0/72
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
0.00%
0/73
|
1.4%
1/72 • Number of events 1
|
Other adverse events
| Measure |
Fostimon
n=73 participants at risk
|
Gonal-F
n=72 participants at risk
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
spontaneous abortion
|
1.4%
1/73 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Ovarian cyst
|
2.7%
2/73 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
General disorders
tiredness
|
0.00%
0/73
|
1.4%
1/72 • Number of events 1
|
Additional Information
IBSA Clinical Research Manager
IBSA instutut Biochimique SA
Phone: +41 58 360 1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place