Clomid Protocols for Female Infertility
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.12345Why 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.16789
Who Is on the Research Team?
Richard Paulson
Principal Investigator
paulsonivf@havingbabies.com
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ovarian stimulation using either a long Clomid protocol or a 5-day Clomid protocol with GnRH antagonist
Follow-up
Participants are monitored for oocyte retrieval and fertilization outcomes
Long-term Follow-up
Participants are monitored for pregnancy outcomes including clinical pregnancy rate, ongoing pregnancy rate, and live birth rate
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?
2
Treatment groups
Experimental Treatment
Active Control
Clomid with gonadotropins throughout the entire duration of ovarian stimulation without addition of GnRH antagonist
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:
- Infertility in women with polycystic ovary syndrome (PCOS)
- Male hypogonadism
- Infertility in women with polycystic ovary syndrome (PCOS)
- Male hypogonadism
- Infertility in women with polycystic ovary syndrome (PCOS)
- Male hypogonadism
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Citations
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 ...
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 ...
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 ...
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.
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 ...
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.
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 ...
Clomiphene: Uses, Side Effects, Interactions, Pictures, ...
Clomiphene is commonly used in women who are having trouble ovulating to increase their chances of becoming pregnant.
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.
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