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Phase 4 N=188 Randomized Quadruple-blind Treatment

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

Infertility

Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Mean Fertilization Proportion (2PN/Oocytes Collected) — 0.63; 0.55 proportion of oocytes fertilized

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Bravelle(follicle stimulating hormone) (Drug); Saline ( placebo) (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of California, San Francisco
Primary completion
Apr 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Fertilization Proportion (2PN/Oocytes Collected)
0.63; 0.55
SECONDARY
Mature Oocyte Recovery Rate Percentage
69.9; 57.1
SECONDARY
Clinical Pregnancy Rate Percentage
56.8; 46.2

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.

Eligibility Criteria

Inclusion Criteria

  • patients undergoing in vitro fertilization

Exclusion Criteria

  • risk of ovarian hyperstimulation syndrome
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00854373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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