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

May 31, 2011 updated by: IBSA Institut Biochimique SA

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).

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.

Study Overview

Status

Completed

Conditions

Infertility

Intervention / Treatment

Drug: hCG-IBSA

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 Type

Interventional

Enrollment (Anticipated)

144

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Basel, Switzerland, 4031
    - Department of Gynecology and Obstetrics Universitätfrauenklinik
  - Bern, Switzerland, 3010
    - 4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102
  - Geneve, Switzerland, 1211
    - Department of Gynecology and ObstetricsUniversity Hospital
  - Lausanne, Switzerland, 1011
    - 3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total number of oocytes retrieved per patient who received hCG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Adverse events were monitored and collected during all the study period	from day 1 to 35 +/- 7 days after oocytes retrieval
Incidence of moderate or severe OHSS Time Frame: 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	From the day of hCG injection until 35 +/- 7 days after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBSA Institut Biochimique SA

Investigators

Principal Investigator: Dominique de Ziegler, Prof., Départements de Gynécologie/Obstétrique et de Pédiatrie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria