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Study on Ovarian Stimulation Using Follitropin Delta and Dydrogesterone for Women Donating Eggs

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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 effects of a treatment involving two medications, Follitropin delta and Dydrogesterone, on women who are donating their eggs. The study aims to understand how these medications affect the number of egg cells that can be collected from the donors. Follitropin delta is a type of hormone used to stimulate the ovaries, while Dydrogesterone is a hormone that helps prepare the body for pregnancy. The trial will explore how these medications work together during different phases of the menstrual cycle to enhance egg production.

Participants in the study will receive Follitropin delta as a solution for injection, which is administered under the skin using a pre-filled pen. Dydrogesterone will be taken orally in the form of film-coated tablets. The study will compare the effects of these medications when used during the typical follicular phase, which is the first half of the menstrual cycle, and the luteal phase, which is the second half. The goal is to determine the best approach for maximizing the number of egg cells that can be retrieved from donors.

The trial will last for a specific period, during which participants will follow a treatment plan that includes both medications. The study will monitor various factors, such as the number of egg cells collected, the hormonal changes in the body, and the duration of the treatment. This research is important for improving the process of egg donation and could potentially benefit women who are undergoing fertility treatments in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the trial, you will be introduced to the study procedures and provided with detailed information about the medications and their administration. You will be required to sign an informed consent form, confirming your understanding and willingness to participate.

  2. Step 2

    Medication administration

    You will begin taking the medication follitropin delta, which is administered as a solution for injection. This medication is provided in a pre-filled pen and is injected under the skin (subcutaneous use). The dosage and frequency will be determined by the study team based on your specific needs.

    In addition to follitropin delta, you will also take dydrogesterone, which is provided in the form of film-coated tablets. This medication is taken orally, and the dosage and frequency will be specified by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, you will have regular appointments with the study team to monitor your response to the medications. This will include blood tests and ultrasound scans to assess the development of oocytes (egg cells).

    The study team will also monitor your overall health and any side effects you may experience. It is important to report any concerns or unusual symptoms to the study team promptly.

  4. Step 4

    Completion of the trial

    At the end of the trial, the total number of cumulus-oocyte complexes (COCs) retrieved will be evaluated. This is the primary endpoint of the study.

    You will have a final appointment with the study team to discuss the results and any further steps, if necessary. Your participation in the trial will be officially concluded at this point.

Who can join the trial?

5 criteria

  • Women who want to donate their oocytes (eggs).
  • Age between 18 and 36 years old.
  • BMI (Body Mass Index) between 18 and less than 28. BMI is a measure of body fat based on height and weight.
  • Must have signed an informed consent form, which means you understand the study and agree to participate.
  • Have a regular menstrual cycle that lasts between 24 to 35 days.

Who cannot join the trial?

3 criteria

  • Participants must be women who wish to donate their oocytes (eggs).
  • Participants must be within the specified age range for the study.
  • Participants must not be part of a vulnerable population, which means they should not be in a situation that makes it hard for them to make decisions freely.
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Investigated drugs

  • Follitropin delta

    is a medication used to stimulate the ovaries. It helps the ovaries produce more eggs than usual. This is important in fertility treatments, as it increases the chances of retrieving multiple eggs for procedures like in vitro fertilization (IVF). In this trial, Follitropin delta is used to see how well it works in different phases of the menstrual cycle to help produce more eggs.

  • Dydrogesterone

    is a type of hormone similar to progesterone, which is naturally found in the body. It is used to support the lining of the uterus, making it more receptive to a fertilized egg. In this trial, dydrogesterone is used to help create a supportive environment in the uterus during the ovarian stimulation process, which is crucial for successful egg implantation and pregnancy.

What is already known about the treatment

  • Follitropin delta

    Follitropin delta is administered as an injection under the skin, typically in the abdomen or thigh, and is used in the context of ovarian stimulation. It is currently being studied in clinical trials to assess its effectiveness in increasing the number of egg cells retrieved from women who are donating their eggs. The medication works by stimulating the ovaries to produce more eggs, which is achieved by mimicking the natural hormone that encourages egg development. Follitropin delta is classified as a gonadotropin, a type of hormone that plays a crucial role in reproductive processes.

  • Dydrogesterone

    Dydrogesterone is taken orally in the form of tablets and is used to support the luteal phase in women undergoing ovarian stimulation. It is being evaluated in clinical trials to determine its impact on the number of egg cells collected from egg donors when used alongside other stimulation protocols. The medication functions by mimicking the natural hormone progesterone, which helps prepare the uterus for pregnancy and supports early pregnancy stages. Dydrogesterone is classified as a progestogen, a group of hormones involved in the menstrual cycle and pregnancy.

Investigated diseases

Voluntary Oocyte Donation – Voluntary oocyte donation is not a disease but a medical procedure where women choose to donate their eggs for assisted reproductive technologies. The process involves stimulating the ovaries to produce multiple eggs, which are then retrieved for donation. This procedure is typically part of fertility treatments and involves hormonal stimulation to increase the number of eggs available for retrieval. The stimulation process can vary in duration and intensity, depending on the protocol used. The primary goal is to collect a sufficient number of healthy eggs for use in fertility treatments. The procedure is carefully monitored to ensure the safety and well-being of the donor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513998-48-00Protocol codeCS-10459Estimated enrolment50 patientsSponsorUZ Brussel

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