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Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation in Patients With Diminished Ovarian Reserve Undergoing In-vitro Fertilization: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
California
HRC Fertility
RECRUITING
Pasadena
Contact Information
Primary
Richard Paulson
paulsonivf@havingbabies.com
323-409-3026
Backup
Rachel Mandelbaum
mandelbaumivf@havingbabies.com
323-409-3026
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov

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