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

This study has been completed.
Sponsor:
Information provided by:
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00335569
First received: June 9, 2006
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: hCG-IBSA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerance and Clinical Equivalence of hCG- IBSA (IBSA) Versus Ovitrelle (Serono), Both Administered Sub-cutaneously in Women Undergoing in Vitro Fertilization (IVF).

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Total number of oocytes retrieved per patient who received hCG

Secondary Outcome Measures:
  • 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 [ Time Frame: from day 1 to 35 +/- 7 days after oocytes retrieval ] [ Designated as safety issue: Yes ]
    Adverse events were monitored and collected during all the study period

  • Incidence of moderate or severe OHSS [ Time Frame: From the day of hCG injection until 35 +/- 7 days after oocyte retrieval ] [ Designated as safety issue: Yes ]
    The incidence moderate or severe of OHSS will be assessed in both treatment groups


Estimated Enrollment: 144
Study Start Date: August 2005
Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335569

Locations
Switzerland
Department of Gynecology and Obstetrics Universitätfrauenklinik
Basel, Switzerland, 4031
4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102
Bern, Switzerland, 3010
Department of Gynecology and ObstetricsUniversity Hospital
Geneve, Switzerland, 1211
3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Dominique de Ziegler, Prof. Départements de Gynécologie/Obstétrique et de Pédiatrie
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00335569     History of Changes
Other Study ID Numbers: 04CH/HCG02
Study First Received: June 9, 2006
Last Updated: May 31, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by IBSA Institut Biochimique SA:
Infertility, sterility, hCG, IVF

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Chorionic Gonadotropin
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014