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

Part of paid clinical trials in Pasadena, California.

Sponsor
University of Southern California
Study ID
NCT06701071
Phase
PHASE4
Status
Recruiting
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Conditions

  • Infertility, Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Long Clomid
    Clomid with gonadotropins throughout the entire duration of ovarian stimulation without addition of GnRH antagonist
  • Active Comparator: 5-day Clomid
    Clomid only for 5 days at beginning of ovarian stimulation with gonadotropins, with GnRH antagonist added when the lead follicle reaches \~14mm.

Primary Outcome Measure

Number of mature oocytes [ Time Frame: Up to 1 month after study completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HRC FertilityPasadenaCalifornia91101
Adriana Wong, MD MPH
[email protected]
866-472-4483
Richard Paulson, MD
[email protected]
866-472-4483
Adriana Wong, MD MPH (SUB_INVESTIGATOR)

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