Recruiting

Clomid vs. GnRH Antagonist

Sponsor:

University of Southern California

Code:

NCT06701071

Conditions

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Clomiphene Citrate

Study Details

Brief 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.

Conditions

Infertility, Female

Study ID

NCT06701071

Start date

Jun 1, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Clomiphene Citrate

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bonnie Song, MD

323-409-3026Bonnie.Song@med.usc.edu

Rachel Mandelbaum

323-409-3026mandelbaumivf@havingbabies.com

Locations

HRC Fertility

Recruiting

Pasadena, California, United States, 91101

Contacts

Bonnie Song, MD

866-472-4483bonnie.song@med.usc.edu

Richard Paulson, MD

866-472-4483paulsonivf@havingbabies.com

More Information

Sponsor

University of Southern California

Last update posted

Aug 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-08-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.