Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation in Patients With Diminished Ovarian Reserve Undergoing In-vitro Fertilization: a Randomized Controlled Trial
University of Southern California
Summary
The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of mature eggs retrieved.
Description
Clomiphene citrate (Clomid) is often used for assisted reproductive technologies and may be used to augment ovarian stimulation with exogenous gonadotropins by stimulating pituitary follicle-stimulating hormone (FSH) release in addition. The mechanism of action of Clomid is antagonism at the estrogen receptor, and this stimulates FSH release from the pituitary. The typical Clomid-based protocol has involved clomid only given for the first five days of stimulation to allow for endometrial development later in the cycle for a fresh embryo transfer following the oocyte retrieval. This protocol in…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Undergoing IVF * Must meet POSEIDON criteria based on clinic evaluation * Female partner: Antral follicle count of 2 or more and age \<45 at time of stimulation start * Male partner/sperm source: Cannot be azoospermic * Planning freeze-all cycle (regardless of blastocyst or cleavage stage culture) or fresh transfer if randomized to short Clomid group * Planning 36-hour trigger window Exclusion Criteria: * Normal ovarian reserve or good response * Allergy or adverse reaction to Clomid * Minimal stimulation protocols * History of prior premature ovulation
Interventions
- DrugClomiphene Citrate
Clomiphene citrate is an estrogen receptor antagonist that leads to pituitary FSH release and prevention of the LH surge.
Location
- HRC FertilityPasadena, California