Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT00335725 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Follicle Stimulating Hormone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Oocytes Retrieved |
10.9; 12.0 | — |
| SECONDARY Clinical Pregnancy Rate |
30.1; 29.2 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the following characteristics:
>/= 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 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
Data sourced from ClinicalTrials.gov (NCT00335725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.