Status:
COMPLETED
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-41 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, single center clinical trial study to compare oocyte competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chor...
Detailed Description
The success rate of assisted reproductive technology (ART) has dramatically increased due to the improvements in embryo culture, laboratory conditions, and optimization of different ovarian stimulatio...
Eligibility Criteria
Inclusion
- The target population includes couples undergoing IVF. All eligible couples will be asked to join the study. Study participants will be recruited from the Reproductive Endocrinology Clinic at University of California at San Francisco Center for Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be offered participation in the study.
Exclusion
- Age \>41 years old
- Antral Follicle Count (AFC; 2-10 mm) \< 8
- Body Mass Index \> 30 kg/m2
- History of ≥ 2 prior canceled IVF cycles secondary to poor response
- Diagnosis of cancer
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
- Undergoing embryo co-culture
- Use of any of the following medications: Growth Hormone, Sildenafil, or Aspirin (except if being used for hypercoagulable state)
- Severe male factor infertility diagnosis. Male factor infertility diagnosis should be cleared for eligibility by the PI based on previous patient history of fertilization outcomes and/or expected fertilization outcomes of the cause of male factor infertility based on known scientific data.
- Ovulation trigger less than or greater than 36 hours to oocyte retrieval
- Serum estradiol level \>5,000 pg/ml on the day of expected trigger due to high risk of OHSS
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02310919
Start Date
September 1 2014
End Date
June 20 2018
Last Update
April 29 2022
Active Locations (1)
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1
University of California at San Francisco
San Francisco, California, United States, 94143