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Sponsored by: |
IBSA Institut Biochimique SA |
Information provided by: | IBSA Institut Biochimique SA |
ClinicalTrials.gov Identifier: | NCT00335569 |
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 III |
MedlinePlus related topics: | Infertility |
ChemIDplus related topics: | Chorionic gonadotropin Choriogonadotropin Alfa |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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). |
Estimated Enrollment: | 144 |
Study Start Date: | August 2005 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |||||
Department of Gynecology and ObstetricsUniversity Hospital | Recruiting | ||||
Geneve, Switzerland, 1211 | |||||
Contact: Dominique de Ziegler, Prof. 022.382.45.68 ext +41 | |||||
Contact: Suzanne Duperret, Secrétariat 022.382.46.06 ext +41 | |||||
Principal Investigator: Dominique de Ziegler, Prof. | |||||
Department of Gynecology and Obstetrics Universitätfrauenklinik | Recruiting | ||||
Basel, Switzerland, 4031 | |||||
Contact: Christian De Geyter, Prof. (61) 265 93 15 ext +41 | |||||
Principal Investigator: Christian de Geyter, Prof. | |||||
4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102 | Recruiting | ||||
Bern, Switzerland, 3010 | |||||
Contact: Martin Birkhäuser, prof. 031 632 13 10 ext +41 | |||||
Principal Investigator: Martin Birkhäuser, Prof. | |||||
3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois | Recruiting | ||||
Lausanne, Switzerland, 1011 | |||||
Contact: Dominique De Ziegler, Prof. (021) 314 32 88 ext +41 | |||||
Principal Investigator: Dominique De Ziegler, Prof. |
IBSA Institut Biochimique SA |
Principal Investigator: | Dominique de Ziegler, Prof. | Départements de Gynécologie/Obstétrique et de Pédiatrie |
Study ID Numbers: | 04CH/HCG02 |
First Received: | June 9, 2006 |
Last Updated: | May 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00335569 |
Health Authority: | Switzerland: Swissmedic |
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