Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial
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.
|Infertility||Drug: Bravelle(follicle stimulating hormone) Other: Saline ( placebo)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Concomitant Administration of FSH With HCG Improves Oocyte Maturation and Quality Double -Blinded Randomized Trial|
- Mean Fertilization Proportion (2PN/Oocytes Collected) [ Time Frame: 24 hours after IVF or intracytoplasmic sperm injection (ICSI) ]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).
- Mature Oocyte Recovery Rate [ Time Frame: 36 hours after hCG trigger ]Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary.
- Pregnancy [ Time Frame: 6 weeks after embryo transfer ]Fetal heart motion by transvaginal ultrasound
|Study Start Date:||June 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Drug: Bravelle(follicle stimulating hormone)
One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger.
Placebo Comparator: 2
Other: Saline ( placebo)
1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854373
|United States, California|
|UCSF- Mount Zion|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Mitchell P Rosen, MD||University of California, San Francisco|