Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Prospective, Multicenter, Investigator Blinded, Randomized, Concurrent Control Study of Efficacy and Tolerability of Two FSH Preparations (Fostimon® Versus Gonal-F®) in Women Undergoing IVF|
- The primary endpoint is the total number of oocytes retrieved.
- Total FSH dose (IUs);number of days of FSH stimulation and stimulation duration;number of follicles >14 mm on the day of hCG injection;
- 17-β estradiol (E2) serum concentration on the day of hCG injection;cancellation rate with reasons;
- Fertilization rate: number of 2PN (or already cleaved) embryos;
- Total number of embryos,number transferred, frozen and discarded;implantation rate;number of transferred embryos; clinical pregnancy rate, per stimulated cycle, per oocyte retrieval and per embryo transfer.
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||May 2005|
This is a prospective, multicenter, investigator blinded, randomized, concurrent control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (Fostimon®, IBSA) or the reference drug (Gonal-F®, Serono Inc.). 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.
|United States, California|
|Fertility Physicians of Northern California|
|Palo Alto, California, United States, 94301|
|San Diego Fertility Center|
|San Diego, California, United States, 92130|
|UCSF In Vitro Fertilization|
|San Francisco, California, United States, 94115-0916|
|United States, Washington|
|Seattle Reproductive Medicine|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Valerie Baker, MD||Fertility Physicians of Northern California|
|Principal Investigator:||Victor Y Fujimoto, MD||UCSF In Vitro Fertilization|
|Principal Investigator:||L. Michael Kettel, MD||San Diego Fertility Center|
|Principal Investigator:||Michael R Soules, MD||Seattle Reproductive Medicine|