About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Normal ovarian reserve or good response
Allergy or adverse reaction to Clomid
Minimal stimulation protocols
History of prior premature ovulation
Trial design
Parallel
Treatments tested in this trial
Clomiphene Citrate
DrugClomiphene citrate is an estrogen receptor antagonist that leads to pituitary FSH release and prevention of the LH surge.
Treatment groups
Trial outcomes
Primary outcomes
Number of mature oocytes
The number of mature oocytes retrieved at oocyte retrieval
Secondary outcomes
Number of participants that experience premature ovulation
Premature LH surge, progesterone rise and estradiol decrease, or evidence of premature ovulation (no oocytes on retrieval or free fluid and follicular collapse on ultrasound)
Number of oocytes that get fertilized and grow to the blastocyst stage
Fertilization rate and blastulation
Pregnancy outcomes
Clinical pregnancy rate, ongoing pregnancy rate, live birth rate
Sponsors and contacts
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