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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00854373 |
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 |
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Infertility |
Drug: Bravelle(follicle stimulating hormone) Other: Saline ( placebo) |
Phase IV |
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 |
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 |
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1: Experimental
Bravelle
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Drug: Bravelle(follicle stimulating hormone)
One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.
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2: Placebo Comparator
Saline
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Other: Saline ( placebo)
1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mitchell P Rosen, MD | 415-353-7475 | rosenm@obgyn.ucsf.edu |
Contact: Marcelle I Cedars, MD | 415-353-7475 | marcelle.cedars@ucsfmedctr.org |
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 |
Principal Investigator: | Mitchell P Rosen, MD | University of California, San Francisco |
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 |
Infertility Pregnancy in vitro fertilization |
Genital Diseases, Female Infertility Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Genital Diseases, Male Hormones Follicle Stimulating Hormone |
Genital Diseases, Female Infertility Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Genital Diseases, Male Hormones Pharmacologic Actions Follicle Stimulating Hormone |