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

NCT06701071 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HS-23-00039
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of mature oocytes

  The number of mature oocytes retrieved at oocyte retrieval

  Up to 1 month after study completion

Secondary Outcomes (3)

• Number of participants that experience premature ovulation

  Up to 1 month after study completion

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

  Up to 1 month after study completion

• Pregnancy outcomes

  Up to 3 years after study completion

Study Arms (2)

Long Clomid

EXPERIMENTAL

Clomid with gonadotropins throughout the entire duration of ovarian stimulation without addition of GnRH antagonist

Drug: Clomiphene Citrate

5-day Clomid

ACTIVE COMPARATOR

Clomid only for 5 days at beginning of ovarian stimulation with gonadotropins, with GnRH antagonist added when the lead follicle reaches \~14mm.

Drug: Clomiphene Citrate

Interventions

Clomiphene Citrate DRUG

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

5-day Clomid; Long Clomid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females can undergo ovarian stimulation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Normal ovarian reserve or good response
• Allergy or adverse reaction to Clomid
• Minimal stimulation protocols
• History of prior premature ovulation

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

HRC Fertility

Pasadena, California, 91101, United States

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Richard Paulson

  paulsonivf@havingbabies.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Paulson

CONTACT

323-409-3026; paulsonivf@havingbabies.com

Rachel Mandelbaum

CONTACT

323-409-3026; mandelbaumivf@havingbabies.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized to the two treatment arms

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: November 22, 2024
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)