Status:
COMPLETED
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
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 admi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00335725
Start Date
March 1 2003
End Date
December 1 2005
Last Update
March 27 2015
Active Locations (7)
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1
Private Consulting
Bron, France
2
Hôpital Jeanne de Flandre
Lille, France
3
Hôpital Edouard Herriot
Lyon, France
4
Institut de Médecine de la Reproduction
Marseille, France