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Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial
This study is currently recruiting participants.
Verified by University of California, San Francisco, February 2009
First Received: March 2, 2009   No Changes Posted
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00854373
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Bravelle(follicle stimulating hormone)
Other: Saline ( placebo)
Phase IV

MedlinePlus related topics: Infertility
Drug Information available for: Urofollitropin Follitropin beta Follicle Stimulating Hormone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Official Title: Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Fertilization rate [ Time Frame: 24 hours after IVF or ICSI ] [ Designated as safety issue: No ]
  • Mature oocytes [ Time Frame: After egg retrieval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rates [ Time Frame: 6 weeks after embryo transfer with pregnancy ultrasound. 9 months for live birth. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Bravelle
Drug: Bravelle(follicle stimulating hormone)
One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.
2: Placebo Comparator
Saline
Other: Saline ( placebo)
1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing in vitro fertilization

Exclusion Criteria:

  • risk of ovarian hyperstimulation syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854373

Contacts
Contact: Mitchell P Rosen, MD 415-353-7475 rosenm@obgyn.ucsf.edu
Contact: Marcelle I Cedars, MD 415-353-7475 marcelle.cedars@ucsfmedctr.org

Locations
United States, California
UCSF- Mount Zion Recruiting
San Francisco, California, United States, 94115
Contact: Mitchellq P Rosen, MD     415-353-7475     rosenm@obgyn.ucsf.edu    
Contact: Marcelle I Cedars, MD     415-353-7475     marcelle.cedars@ucsfmedctr.org    
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mitchell P Rosen, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco ( Center for Reproductive Health )
Study ID Numbers: MR-9999
Study First Received: March 2, 2009
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00854373     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Infertility
Pregnancy
in vitro fertilization

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Diseases, Male
Hormones
Follicle Stimulating Hormone

Additional relevant MeSH terms:
Genital Diseases, Female
Infertility
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Diseases, Male
Hormones
Pharmacologic Actions
Follicle Stimulating Hormone

ClinicalTrials.gov processed this record on May 06, 2009