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Study on Pregnancy Rates in Women with Polycystic Ovary Syndrome Using Letrozole and Gonadotropins

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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 the effectiveness of two different treatments for women with Polycystic Ovary Syndrome (PCOS), a condition that affects the ovaries and can lead to fertility issues. The study compares the use of a medication called Letrozole with a group of medications known as gonadotropins, which include GONAL-f, Ovaleap, Puregon, and Bemfola. These treatments are used to stimulate the ovaries in preparation for artificial insemination, a procedure that helps achieve pregnancy.

The purpose of the study is to determine if Letrozole can be an effective alternative to gonadotropins in terms of pregnancy rates and live birth rates for women undergoing artificial insemination. Participants in the study will receive either Letrozole or one of the gonadotropins for a period of up to 21 days. The study will monitor the number of pregnancies achieved, as well as the number of live births resulting from the treatments. Additionally, the study will observe other factors such as the number of follicles (small sacs in the ovaries) that develop, any cancellations due to lack of response or over-response to the treatment, and any side effects like insulin resistance or gestational diabetes.

Throughout the study, participants will undergo regular check-ups, including ultrasounds to monitor the development of follicles and blood tests to assess hormone levels. The study aims to provide valuable information on the effectiveness and safety of these treatments for women with PCOS who are seeking to become pregnant through artificial insemination.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, body mass index, and diagnosis of polycystic ovary syndrome (PCOS).
Step 2
Treatment assignment
Participants are assigned to one of two treatment groups: one receiving letrozole and the other receiving gonadotropins.
Step 3
Medication administration
For the letrozole group, the medication is taken orally. The dosage and frequency are determined by the study protocol.
For the gonadotropin group, medications such as GONAL-f, Ovaleap, Puregon, or Bemfola are administered via subcutaneous injection. The dosage and frequency are specified in the study protocol.
Step 4
Monitoring and ultrasound
Participants undergo regular monitoring, including ultrasound examinations to assess the development of follicles. The number of dominant follicles is recorded.
Step 5
Insemination procedure
Once the follicles reach the appropriate size, the insemination procedure is performed.
Step 6
Pregnancy testing
A urine pregnancy test is conducted between the 15th and 17th day after insemination to determine if gestation has occurred.
Step 7
Follow-up and data collection
Participants are followed up to collect data on pregnancy outcomes, including gestation rates and live birth rates. Additional data such as insulin resistance, BMI, and perinatal outcomes are also collected.

Who can join the trial?

6 criteria

Women must be between 18 and 40 years old.
Body mass index (BMI) should be between 18 and 30. BMI is a measure that uses your height and weight to work out if your weight is healthy.
Must have primary or secondary infertility. Infertility means having difficulty getting pregnant.
Must have a diagnosis of **PCOS**. PCOS stands for **polycystic ovary syndrome**, a condition that affects a woman's hormone levels.
Must have a recommendation for insemination. Insemination is a medical procedure to help with pregnancy.
Must agree to participate in the study by giving informed consent. This means understanding the study and agreeing to take part.

Who cannot join the trial?

4 criteria

Patients who do not have polycystic ovary syndrome cannot participate. Polycystic ovary syndrome is a condition that affects a woman's hormone levels.
Patients who are not female cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.

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Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Letrozole
is a medication used in this study to help stimulate the ovaries in patients with polycystic ovary syndrome. It works by reducing the amount of estrogen in the body, which can help the ovaries produce eggs. The study aims to see if letrozole can be an effective alternative to other treatments in helping women become pregnant.
Gonadotropins
are another type of medication used in the study to stimulate the ovaries. These are hormones that directly encourage the ovaries to produce eggs. The study compares the effectiveness of gonadotropins with letrozole in achieving pregnancy and live birth rates in women with polycystic ovary syndrome.

What is already known about the treatment

Letrozole
Letrozole is taken orally in tablet form and is currently used in medical practice, with ongoing research to explore its effectiveness in treating polycystic ovary syndrome (PCOS) for artificial insemination. It is primarily indicated for stimulating ovulation in women with PCOS. Letrozole works by inhibiting the enzyme aromatase, which reduces estrogen production and stimulates the release of hormones necessary for ovulation. It is classified as an aromatase inhibitor.
Gonadotropins
Gonadotropins are administered through injections and are well-established in medical literature for their role in fertility treatments, including their use in patients with polycystic ovary syndrome undergoing artificial insemination. They are used to stimulate the ovaries to produce multiple eggs. Gonadotropins act by directly stimulating the ovaries to produce and mature eggs, mimicking the natural hormones that regulate the reproductive cycle. They belong to the class of fertility medications known as gonadotropins.

Investigated diseases

Polycystic Ovary Syndrome (PCOS) – Polycystic Ovary Syndrome is a hormonal disorder common among women of reproductive age. Women with PCOS may have infrequent or prolonged menstrual periods or excess male hormone (androgen) levels. The ovaries may develop numerous small collections of fluid (follicles) and fail to regularly release eggs. The exact cause of PCOS is unknown, but it is believed to involve a combination of genetic and environmental factors. Over time, PCOS can lead to complications such as infertility, metabolic issues, and increased risk of type 2 diabetes. The condition often begins at puberty and can persist throughout a woman's reproductive years.