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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00854373
First received: March 2, 2009
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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 ]

Enrollment: 239
Study Start Date: June 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bravelle
 Drug: Bravelle(follicle stimulating hormone)
One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.
Placebo Comparator: 2
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

Locations
United States, California
UCSF- Mount Zion
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mitchell P Rosen, MD University of California, San Francisco
  More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00854373     History of Changes
Other Study ID Numbers: MR-9999
Study First Received: March 2, 2009
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013