Infertility
Conditions
Keywords
Ovarian stimulation, Infertility, ICSI, FSH
Brief summary
Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI
Detailed description
This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria. In effect, a double blind trial is not really feasible since the drugs presentations are very different. However, in IVF, drugs are usually dispensed and/or injected by a nurse and therefor the Investigator can be blind. Moreover, the used preparations will contain the same amount of gonadotrophin units (75 IU), will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet: You are required not to inform the Investigator about the product's name. The randomisation is necessary to get groups as comparable as possible for all the other aspects. The multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.
Interventions
subcutaneous injection of FSH. Starting dose: 225 IU.
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics: \>/= 18 and \< 40 years old BMI between 19 and 30 kg/m2 less than 3 previous completed cycles basal FSH level less than 10 IU/l within the 6 months prior to the study
Exclusion criteria
age \< 18 and \>/= 40 years primary ovarian failure or women known as poor responders, i.e. requiring more than 225 IU of FSH as starting dose in previous treatment cycles or having less than 3 oocytes retrieved or with an oestradiol serum concentration \< 900 pmol/l (250 pg/ml) ovarian cysts \> 20 mm oocyte donation thawed embryos replacement patients affected by pathologies associated with any contraindication of being pregnant ascertained or presumptive hypersensitivity to the active principle and/or their ingredients abnormal bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias severe impairment of the renal and/or hepatic functions women deprived of their freedom by administrative or legal decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Oocytes Retrieved | 10 days after stimulation start | Total number of oocytes retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | 6 weeks after treatment start | clinical pregnancy rate defined as the presence of gestation sac and heart beat. |
Countries
France, Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fostimon | 75 |
| Gonal-f | 76 |
| Total | 151 |
Baseline characteristics
| Characteristic | Fostimon | Gonal-f | Total |
|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 4 | 30.0 years STANDARD_DEVIATION 3.6 | 30.0 years STANDARD_DEVIATION 3.8 |
| basal FSH | 5.9 IU/L STANDARD_DEVIATION 2.5 | 6.0 IU/L STANDARD_DEVIATION 1.9 | 6.0 IU/L STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 75 Participants | 76 Participants | 151 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 73 | 3 / 72 |
| serious Total, serious adverse events | 2 / 73 | 5 / 72 |
Outcome results
Primary
Total Number of Oocytes Retrieved
Total number of oocytes retrieved
Time frame: 10 days after stimulation start
Population: patients who started the stimulation with FSH
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fostimon | Total Number of Oocytes Retrieved | 10.9 oocytes | Standard Deviation 4.9 |
| Gonal-f | Total Number of Oocytes Retrieved | 12.0 oocytes | Standard Deviation 5.6 |
Secondary
Clinical Pregnancy Rate
clinical pregnancy rate defined as the presence of gestation sac and heart beat.
Time frame: 6 weeks after treatment start
Population: patients who started the FSH treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fostimon | Clinical Pregnancy Rate | 30.1 percentage of treated patients |
| Gonal-f | Clinical Pregnancy Rate | 29.2 percentage of treated patients |