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

NCT00854373 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2025-12-12

Study results available
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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.

Conditions

Interventions

DRUG

Bravelle(follicle stimulating hormone)

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

OTHER

Saline ( placebo)

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

Sponsors & Collaborators

Principal Investigators

  • Mitchell P Rosen, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-01
Primary Completion
2010-04-20
Completion
2010-04-20

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00854373 on ClinicalTrials.gov