Clomid Protocols for Female Infertility

Overseen By Rachel Mandelbaum

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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 or egg freezing. 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 eggs retrieved.

Research Team

Richard Paulson

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for women with reduced ovarian function who are undergoing IVF or egg freezing. They should not have participated in similar studies before and must be able to follow the protocol, which includes taking medication and attending follow-up appointments.

Inclusion Criteria

My ovarian reserve is low.

I have had a poor response to fertility treatments before.

Exclusion Criteria

My ovarian function is normal or responds well to treatment.

Allergy or adverse reaction to clomid

I am undergoing or will undergo minimal stimulation treatment.

Treatment Details

Interventions

• Clomiphene Citrate (Anti-estrogen)

Trial Overview The study compares a long Clomid (Clomiphene Citrate) protocol against a standard short one for ovarian stimulation. The goal is to see if the longer treatment leads to more eggs being retrieved while reducing costs and injections needed.

Participant Groups

Group I: Long Clomid Experimental Treatment 1 Intervention

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

Group II: 5-day Clomid Active Control 1 Intervention

Clomid only for 5 days starting on day 2 or 3 of menses with gonadotropins, with GnRH antagonist added when the lead follicle reaches \~14mm.

Clomiphene Citrate is already approved in Canada for the following indications:

Approved in Canada as Serophene for:

• Infertility in women with polycystic ovary syndrome (PCOS)
• Male hypogonadism

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+