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

• Status: Completed
• Trial end date: 2018-06-20
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized, double-blind, single center clinical trial study to compare the oocyte maturity, embryo development, and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro fertilization (IVF).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Ferring Pharmaceuticals

Criteria

Inclusion Criteria: 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 Criteria:

• 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, Sildefanil, 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