Phase 3 Completed N=151 Randomized Single-blind Treatment

Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.

Infertility

Source: ClinicalTrials.gov NCT00335725 ↗

Enrolled (actual)

151

Serious AEs

4.8%

Results posted

Mar 2015

Primary outcomePrimary: Total Number of Oocytes Retrieved — 10.9; 12.0 oocytes

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Oocytes Retrieved	10.9; 12.0	—
SECONDARY Clinical Pregnancy Rate	30.1; 29.2	—

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

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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. Informational only — not medical advice.