Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Clinical and endocrinological effects of letrozole during the luteal phase after controlled ovarian stimulation in oocyte donors: a low interventional, randomized, controlled trial

This research study is investigating the effects of a medicine called letrozole in women who are donating eggs. After their ovaries have been stimulated (a common part of egg donation), participants will be given letrozole during a specific time in their menstrual cycle. The main goal is to see if letrozole changes the size of the ovaries. Researchers will also be checking various hormone levels, like oestradiol, progesterone, and testosterone, as well as other chemicals in the blood. This is a Phase III trial, which means it's one of the final stages of testing before a new treatment might become widely available. The aim is to gather more information about how letrozole works and its safety in this specific situation.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Ivi Madrid S.L., Ivi Madrid S.L.

Enrolment target

152

Start

17 Mar 2023

Female Infertility

What is this study about?

This research study is looking at a medicine called letrozole. It's designed for women who are donating eggs. Egg donation involves a process where medicines are used to encourage the ovaries to produce several eggs at once. This study wants to see what happens when letrozole is given *after* this stimulation process, specifically during a part of the menstrual cycle called the luteal phase.

The main thing the researchers want to find out is whether letrozole changes the size of a woman's ovaries. They will measure this carefully. They're also interested in how letrozole affects various chemical messages in the body, such as hormones like oestradiol, progesterone, and testosterone, which play key roles in reproduction. By understanding these effects, the study hopes to see if letrozole could be a helpful and safe option for egg donors.

This is a 'Phase III' trial, meaning it's one of the final steps in testing a new treatment or use for an existing one. The information gathered from this study will help doctors and scientists understand if letrozole has a role in managing the effects of ovarian stimulation in egg donors. It’s about building a better understanding to improve future care.

Key takeaways

The study investigates the medicine letrozole in women donating eggs.
Researchers will check how letrozole affects ovary size after ovarian stimulation.
Hormone levels and other body chemicals will also be measured.
It's a Phase III study, meaning it's a key step in understanding this medicine.
Participation contributes to improving understanding of fertility treatments.

Who may be eligible?

To take part in this study, you need to be a woman who is at least 18 years old. There is no upper age limit for participation.

Since this study is specifically for women who are donating eggs, you would need to be going through the process of controlled ovarian stimulation for egg donation to be considered for this trial.

Other specific health requirements, which a doctor or research nurse can explain in detail, would also need to be met to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Are you currently preparing for or undergoing ovarian stimulation for egg donation?
Are you willing to attend regular appointments for blood tests and examinations?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the medicine letrozole during a specific part of your menstrual cycle, after your ovaries have been stimulated for egg donation. This medicine is normally taken by mouth. You would have regular appointments to check your health and hormone levels in your blood. The doctors would also measure the size of your ovaries to see how they are responding. There will be follow-up visits to ensure your well-being. The total duration of your participation would be explained fully by the study team, including how many visits and blood tests are involved.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit could be contributing to important medical knowledge that might help other women in the future undergoing egg donation. It's also possible you might receive closer medical monitoring during your participation. However, there could be side effects from taking letrozole, or discomfort from blood tests and examinations. The full details of potential risks and benefits will be discussed with you in depth by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is letrozole?

Letrozole is a medicine sometimes used to help with fertility by affecting hormone levels. In this study, it's being tested for a different purpose in egg donors.

What does 'ovarian stimulation' mean?

Ovarian stimulation is a process where medicines are given to encourage your ovaries to produce more than one egg, which is common in egg donation.

Will this study affect my ability to donate eggs?

This study is designed for women who are already undergoing egg donation. The study aims to understand the effects of the medicine in this process, but you should discuss any concerns about your egg donation with the study team.

What is a 'Phase III' trial?

Phase III trials are a later stage of research that check if a treatment is safe and works well, often comparing it to existing treatments or a placebo, involving a larger number of people.

How long will I be in the study?

The exact length of your participation, including appointments and follow-up, will be clearly explained by the research team if you are eligible and interested.