Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorUniversity of Southern California

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Clomiphene Citrate

    Drug

    Clomiphene citrate is an estrogen receptor antagonist that leads to pituitary FSH release and prevention of the LH surge.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Long ClomidExperimental treatment 1 intervention
Group B: 5-day ClomidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of mature oocytes

The number of mature oocytes retrieved at oocyte retrieval

Time frame
Up to 1 month after study completion

Secondary outcomes

1

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)

Time frame
Up to 1 month after study completion
2

Number of oocytes that get fertilized and grow to the blastocyst stage

Fertilization rate and blastulation

Time frame
Up to 1 month after study completion
3

Pregnancy outcomes

Clinical pregnancy rate, ongoing pregnancy rate, live birth rate

Time frame
Up to 3 years after study completion

Other outcomes

Sponsors and contacts

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