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

Phase 3

Completed

• Conditions: Infertility

• Registration Number: NCT00335569
• Lead Sponsor: IBSA Institut Biochimique SA

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 patients undergoing IVF.

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 randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Study Completion: 2008-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total number of oocytes retrieved per patient who received hCG

Secondary Outcome Measures

Name	Time	Method
Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,
2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;
Implantation rate;Pregnancy rate.
Adverse Events	from day 1 to 35 +/- 7 days after oocytes retrieval	Adverse events were monitored and collected during all the study period
Incidence of moderate or severe OHSS	From the day of hCG injection until 35 +/- 7 days after oocyte retrieval	The incidence moderate or severe of OHSS will be assessed in both treatment groups

Trial Locations

Locations (4)

4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102; 🇨🇭 Bern, Switzerland

3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Department of Gynecology and Obstetrics Universitätfrauenklinik; 🇨🇭 Basel, Switzerland

Department of Gynecology and ObstetricsUniversity Hospital; 🇨🇭 Geneve, Switzerland