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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of using Clomid (Clomiphene Citrate) to assist women with a low number of eggs in their ovaries during in-vitro fertilization (IVF). The researchers aim to determine if a longer duration of Clomid use can yield more mature eggs, lower costs, and reduce the number of injections needed. Participants will be randomly assigned to either a typical 5-day Clomid plan or an extended Clomid plan. This trial suits women undergoing IVF who have been informed of a limited egg supply and are not allergic to Clomid. As a Phase 4 trial, Clomid is already FDA-approved and proven effective, and this research seeks to understand how it can benefit more patients.

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 is the safety track record for Clomiphene Citrate?

Research has shown that clomiphene citrate, often called Clomid, has been safely used for many years to help women ovulate and improve their chances of becoming pregnant. Studies have found no serious harmful effects from short-term use of clomiphene citrate. Some women might experience mild side effects like nausea.

Some evidence suggests a possible increased risk of certain cancers, such as uterine and breast cancer, with long-term use. However, these findings are not conclusive, and more research is needed. Overall, clomiphene citrate is considered safe for its intended use. For any concerns, consulting a healthcare professional is recommended. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these Clomid protocols for female infertility because they explore different strategies for using Clomiphene Citrate, a well-known medication in fertility treatments. The "5-day Clomid" approach adds Clomid at the start of ovarian stimulation with gonadotropins, followed by a GnRH antagonist, potentially optimizing timing for better results. Meanwhile, the "Long Clomid" method uses Clomid with gonadotropins throughout the entire stimulation period, differing from standard short-term use. These protocols aim to improve the effectiveness and flexibility of infertility treatments, offering hope for personalized approaches in fertility care.

What evidence suggests that this trial's treatments could be effective for female infertility?

This trial will compare two different Clomid protocols for female infertility. Studies have shown that Clomiphene Citrate (Clomid) effectively aids women with fertility issues by stimulating the ovaries to produce more eggs, which is crucial for those with fewer eggs than usual. Research indicates that Clomid can reduce the need for additional hormones, simplifying the treatment. It has also proven effective for women who do not ovulate regularly, increasing their chances of pregnancy. Overall, Clomid is a well-established treatment for improving fertility in women with ovulation difficulties. ^{1 6 7 8 9}

Who Is on the Research Team?

Richard Paulson

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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

I have had a poor response to fertility treatments before.

My ovarian reserve is low.

Exclusion Criteria

Allergy or adverse reaction to clomid

History of prior premature ovulation

My ovarian function is normal or responds well to treatment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 at beginning of ovarian stimulation 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+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559292/

Clomiphene - StatPearls - NCBI Bookshelf Ovarian hyperstimulation syndrome (OHSS) is reported in patients using clomiphene citrate therapy for ovulation induction. OHSS can progress rapidly (within 24 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211520302931

The addition of clomiphene citrate to ovarian stimulation ... The use of Clomiphene Citrate (CC) has been shown to improve ovarian stimulation outcomes and decrease gonadotropin requirements in women of advanced ...

3. asrm.org asrm.org/practice-guidance/practice-committee-documents/evidence-based-treatments-for-couples-with-unexplained-infertility-a-guideline-2020/

Evidence-based treatments for couples with unexplained ... There is strong evidence that clomiphene citrate with IUI is superior to expectant management and natural-cycle IUI for the outcome of live-birth rate in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052733/

Clomiphene citrate for unexplained subfertility in women - PMC The effectiveness of clomiphene citrate has been demonstrated in the treatment of subfertility associated with infrequent or irregular ovulation.

5. academic.oup.com academic.oup.com/humupd/article/28/5/733/6588517

Ovarian stimulation strategies for intrauterine insemination in ... Gonadotrophins, letrozole and clomiphene citrate (CC) are commonly used agents during IUI-OS and have been compared in multiple aggregate data ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/clomiphene-oral-route/description/drg-20063072

Clomiphene (oral route) - Side effects & dosage Clomiphene probably works by changing the hormone balance of the body. In women, this causes ovulation to occur and prepares the body for pregnancy.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf

Clomid (clomiphene citrate) tablets label In addition, available data do not support an increased rate of spontaneous abortion among subfertile women treated with clomiphene citrate for ovulation ...

8. webmd.com webmd.com/drugs/2/drug-11204/clomid-oral/details

Clomiphene: Uses, Side Effects, Interactions, Pictures, ... Clomiphene is commonly used in women who are having trouble ovulating to increase their chances of becoming pregnant.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5851961/

Safety of clomiphene citrate: a literature review Women who used drugs, especially CC to induce ovulation (n = 567) had increased risks of uterine and breast cancer, malignant melanoma and Non-Hodgkin lymphoma.