NCT00335569

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

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	hCG-IBSA

Timeline

• Start date: 2005-08-01
• Completion: 2008-12-01
• First posted: 2006-06-12
• Last updated: 2011-06-01

Locations

4 sites across 1 country: Switzerland