Status:
COMPLETED
Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to ...
Detailed Description
This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randoml...
Eligibility Criteria
Inclusion
- \>/=18 and \< 40 years old;
- BMI between 18 and 30 kg/m2;
- less than 3 previous completed cycles;
- both ovaries present;
- regular menstrual cycle of 25-35 days;
- infertility attributable to a tubal factor, American Fertility Society grade I or II endometriosis, male factor or unexplained factor.
- within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through hysterosalpingogram, sonohystrogram or hysteroscopic examination;
- basal FSH level less than 10 IU/L;
- criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16 mm or more, with acceptable serum E2 concentration).
- a male partner with semen analysis within the past 6 months showing acceptable values of seminal parameters, defined as \> 3x10 exp 6 spermatozoa/ml;
- qualified to receive 150 - 300 IU FSH as starting dose.
Exclusion
- age \< 18 and \> o = 40 years;
- primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration \< 3'000 pmol/L);
- ovarian cysts \> 20 mm, or enlargement not due to polycystic ovarian syndrome;
- patients affected by pathologies associated with any contraindication of being pregnant;
- hypersensitivity to the study medication;
- any bleeding since stimulation;
- uncontrolled thyroid or adrenal dysfunction;
- neoplasias;
- severe impairment of the renal and/or hepatic functions;
- use of concomitant medication that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents);
- more than 18 days of FSH stimulation.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00335569
Start Date
August 1 2005
End Date
December 1 2008
Last Update
June 1 2011
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gynecology and Obstetrics Universitätfrauenklinik
Basel, Switzerland, 4031
2
4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102
Bern, Switzerland, 3010
3
Department of Gynecology and ObstetricsUniversity Hospital
Geneva, Switzerland, 1211
4
3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011