Clomid Protocols for Female Infertility

Overseen By Rachel Mandelbaum

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Southern California

Disqualifiers: Normal ovarian reserve, Allergy to clomid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 month

60 Participants Needed

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Clomiphene Citrate for female infertility?

Clomiphene Citrate is effective for women with certain types of infertility, particularly those who do not ovulate regularly. It helps stimulate ovulation, and many women respond well to it, achieving pregnancy rates similar to those in the general population after several cycles of treatment. ^{1 2 3 4 5}

Is Clomiphene Citrate safe for use in humans?

Clomiphene Citrate is generally well tolerated in humans, with no serious adverse effects identified in studies for male infertility. However, in women, it can increase the risk of multiple pregnancies, which can be managed with careful monitoring. ^{6 7 8 9 10}

What makes the drug Clomiphene Citrate unique for treating female infertility?

Clomiphene Citrate is unique because it is often the first choice for women with ovulation issues, working by stimulating the release of hormones needed for ovulation. Unlike other treatments like gonadotrophins, it is less expensive and can be effective for up to six cycles, although combining it with other drugs may enhance its effectiveness. ^{1 9 11 12 13}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ovarian stimulation using either a long Clomid protocol or a 5-day Clomid protocol with GnRH antagonist

Up to 1 month

Follow-up

Participants are monitored for oocyte retrieval and fertilization outcomes

Up to 1 month

Long-term Follow-up

Participants are monitored for pregnancy outcomes including clinical pregnancy rate, ongoing pregnancy rate, and live birth rate

Up to 3 years

Treatment Details

Interventions

• Clomiphene Citrate

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 United States, Canada, European Union for the following indications:

Approved in United States as Clomid for:

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

Approved in Canada as Serophene for:

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

Approved in European Union as Clomiphene Citrate 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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clomiphene citrate versus gonadotrophins for ovulation stimulation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Enhanced follicular recruitment in an in vitro fertilization program: clomiphene alone versus a clomiphene/human menopausal gonadotropin combination. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Recombinant FSH versus clomiphene citrate for ovarian stimulation in couples with unexplained infertility and male subfertility undergoing intrauterine insemination: a randomized trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Modern use of clomiphene citrate in induction of ovulation. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Follicle-stimulating hormone modestly predicts improvement in semen parameters in men with infertility treated with clomiphene citrate. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Clomiphene ovulation induction and higher-order multiple pregnancy. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Induction of sister chromatid exchanges and cell division delays by clomiphene citrate in human lymphocytes. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Clomiphene for the treatment of male infertility. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Luteal phase clomiphene citrate for ovulation induction in women with polycystic ovary syndrome: a novel protocol. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Subclinical pregnancy loss in clomiphene citrate-treated women. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of two brands of clomiphene citrate for stimulation of follicular development in a program for in vitro fertilization. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The effect of time of initiation of clomiphene citrate on multiple follicle development for human in vitro fertilization and embryo replacement procedures. [2019]

13. Singapore pubmed.ncbi.nlm.nih.gov

Effects of clomiphene citrate on neonatal rat skin. [2020]