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Study on Letrozole and Gonadotropins for Women with Polycystic Ovary Syndrome (PCOS) to Improve Live Birth Rates

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for Polycystic Ovary Syndrome (PCOS), a condition that affects women's hormone levels, often leading to irregular menstrual cycles and difficulty in getting pregnant. The study will compare two different treatments to help women with PCOS who wish to become pregnant. The first treatment involves continuing the use of letrozole, a medication taken orally in the form of a film-coated tablet. The second treatment involves switching to gonadotropins, which are hormones used to stimulate the ovaries and are administered through injections. The specific types of gonadotropins used in this study are human menopausal gonadotropins and follitropin alfa.

The purpose of the study is to determine which treatment is more effective in improving the chances of having a live birth. Participants will be randomly assigned to either continue with letrozole or switch to gonadotropins. The study will monitor the participants over a period of up to eight months to see if they become pregnant and have a live birth. During this time, the study will also look at other outcomes such as the number of pregnancies, any pregnancy complications, and the overall health and well-being of the participants.

Participants will be asked to keep a medication diary and complete questionnaires about their quality of life and mental health at different points during the study. The study will also assess the cost-effectiveness of the treatments by considering the costs involved and the quality of life of the participants. The goal is to provide valuable information that can help improve treatment options for women with PCOS who are trying to conceive.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.
Step 2
Treatment with letrozole
If assigned to the letrozole group, you will continue taking letrozole orally. The dosage and frequency will be determined by the study team based on your specific needs.
This treatment will continue for up to 8 months, during which your response to the medication will be monitored.
Step 3
Treatment with gonadotropins
If assigned to the gonadotropins group, you will switch to receiving gonadotropins, which include human menopausal gonadotrophins and follitropin alfa. These are administered through subcutaneous injections.
The dosage and frequency of these injections will be tailored to your individual response and monitored by the study team over the course of up to 8 months.
Step 4
Monitoring and assessments
Throughout the study, your progress will be closely monitored. This includes regular assessments of your health and response to the treatment.
You will be asked to maintain a medication diary and complete questionnaires at 3 months and 8 months after randomization to assess side effects and compliance.
Step 5
Quality of life and mental health evaluation
Your quality of life and mental health will be evaluated using specific questionnaires at the time of randomization, and again at 3 months and 6 months after randomization.
Step 6
End of study evaluation
At the end of the study period, which lasts up to 8 months, the primary goal is to determine if a pregnancy leading to a live birth has occurred.
Secondary outcomes such as clinical pregnancy, ongoing pregnancy, and any pregnancy complications will also be assessed.

Who can join the trial?

4 criteria

Couples or single women who wish to have a child.
Diagnosed with Polycystic Ovary Syndrome (PCOS). This means having a condition where the ovaries have many small cysts, and there may be symptoms like excessive acne, hair loss, or unwanted hair growth. It can also be diagnosed by high levels of certain hormones in the blood.
Age between 18 and 43 years.
Have been able to ovulate (release an egg) for six cycles while on letrozole treatment. Letrozole is a medication used to help stimulate the ovaries to release eggs.

Who cannot join the trial?

4 criteria

Patients who do not have Polycystic Ovary Syndrome (PCOS) cannot participate.
Only women can participate; men are not eligible.
Participants must be within a specific age range (details not provided).
Individuals who are part of a vulnerable population are not eligible. This means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands

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Investigated drugs

Letrozole
is a medication used to help women with polycystic ovary syndrome (PCOS) to ovulate, which means to release an egg from the ovary. It works by lowering the levels of certain hormones in the body, which can help stimulate the ovaries to produce and release eggs. This medication is often used in women who have difficulty getting pregnant due to problems with ovulation.
Gonadotropins
are a type of hormone therapy used to stimulate the ovaries to produce multiple eggs. These hormones are similar to the natural hormones in the body that control the reproductive system. In women with PCOS, gonadotropins can help improve the chances of ovulation and increase the likelihood of pregnancy. They are usually given as injections and are used when other treatments, like letrozole, are not successful in helping a woman to ovulate.

What is already known about the treatment

Letrozole
Letrozole is taken orally in the form of a tablet and is used to help women with polycystic ovary syndrome (PCOS) to ovulate. It is currently well-documented in medical literature as a treatment option for inducing ovulation. The main therapeutic use of letrozole is to stimulate ovulation in women who have difficulty becoming pregnant due to PCOS. At the molecular level, letrozole works by blocking an enzyme called aromatase, which leads to a decrease in estrogen production and stimulates the ovaries to release eggs. It is classified as an aromatase inhibitor in pharmacology.
Gonadotropins
Gonadotropins are administered through injections and are used to stimulate the ovaries in women with polycystic ovary syndrome (PCOS) to help them ovulate. These hormones are well-established in medical practice for their role in fertility treatments. The primary therapeutic indication for gonadotropins is to promote ovulation in women who have trouble conceiving due to PCOS. They work by directly stimulating the ovaries to produce and release eggs, mimicking the natural hormones that regulate the reproductive cycle. Gonadotropins are classified as fertility hormones in pharmacology.

Investigated diseases

Polycystic Ovary Syndrome (PCOS) – Polycystic Ovary Syndrome is a hormonal disorder common among women of reproductive age. It is characterized by irregular menstrual periods, excess androgen levels, and polycystic ovaries. The condition often leads to the development of numerous small collections of fluid (follicles) in the ovaries and may result in the failure of regular ovulation. Over time, women with PCOS may experience symptoms such as weight gain, acne, and hair growth on the face and body. The progression of PCOS can vary, with some women experiencing worsening symptoms, while others may have periods of improvement. The condition is associated with metabolic issues, including insulin resistance, which can further influence its progression.