CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 232 enrolled
Drug / intervention
Bravelle(follicle stimulating hormone) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00854373
NCT00854373Phase 4Completed

Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial

University of California, San Francisco·interventional·Posted Mar 3, 2009·Updated Dec 12, 2025

In Brief

A Phase 4 clinical trial evaluating Bravelle(follicle stimulating hormone) and Saline ( placebo) for Infertility. Completed, enrolled 232 participants across 1 site.

Detailed Summary

Marcelle Cedars, M.D., Victor Fujimoto, M.D., Mitch Rosen, M.D., Heather Huddleston, M.D., Paolo Rinaudo, M.D., Anthony Dobson, M.D., and Shehua Shen, M.D. from the UCSF Department of Obstetrics and Gynecology and Reproductive Sciences are conducting a study to learn about ovarian stimulation and oocyte maturation to improve fertilization, embryo quality, implantation and clinical pregnancy rates in patients undergoing in vitro fertilization (IVF). Two hormones, follicle stimulating hormone and human chorionic gonadotropin (FSH/hCG) will be compared to the standard one hormone, hCG, for the ovulation trigger. Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase has largely been attributed to improvements in the laboratory conditions and improvements in ovarian stimulation protocols (those medications used to increase the number of eggs maturing each cycle). Less work has been done on different ways to cause the final maturation of the eggs and the release of the egg from the ovary. The investigators propose to change the final injection prior to the egg retrieval (the ovulation trigger) so that it looks more like what happens in a normal menstrual cycle, where two hormones (both luteinizing hormone (LH) and FSH) increase. The investigators want to find out if this will improve egg quality and increase chances for pregnancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 3, 2009
Enrollment StartJun 1, 2007
Primary CompletionApr 20, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.3 years ago

Interventions

Bravelle(follicle stimulating hormone)drug

One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.

Saline ( placebo)other

1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.