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: August 1, 2013
Last verified: August 2013
  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: Parallel 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:


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

Primary Outcome Measures:
  • Mean Fertilization Proportion (2PN/Oocytes Collected) [ Time Frame: 24 hours after IVF or intracytoplasmic sperm injection (ICSI) ] [ Designated as safety issue: No ]
    Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated MII oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).


Secondary Outcome Measures:
  • Mature Oocyte Recovery Rate [ Time Frame: 36 hours after hCG trigger ] [ Designated as safety issue: No ]
    Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary.

  • Pregnancy [ Time Frame: 6 weeks after embryo transfer ] [ Designated as safety issue: No ]
    Fetal heart motion by transvaginal ultrasound


Enrollment: 232
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: May 29, 2013
Last Updated: August 1, 2013
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, Female
Genital Diseases, Male
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014