Infertility Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 232 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients undergoing in vitro fertilization Exclusion Criteria: - risk of ovarian hyperstimulation syndrome |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCSF- Mount Zion | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Lamb JD, Shen S, McCulloch C, Jalalian L, Cedars MI, Rosen MP. Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-bl — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Fertilization Proportion (2PN/Oocytes Collected) | 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). | 24 hours after IVF or intracytoplasmic sperm injection (ICSI) | No |
Secondary | Mature Oocyte Recovery Rate | Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary. | 36 hours after hCG trigger | No |
Secondary | Pregnancy | Fetal heart motion by transvaginal ultrasound | 6 weeks after embryo transfer | No |
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