Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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 patients undergoing IVF.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Chorionic Gonadotropin

Criteria

Inclusion Criteria:

• >/=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 Criteria:

• 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.