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Study on Random Start Ovarian Stimulation with Follitropin Alfa, Dydrogesterone, and Triptorelin Acetate for Women Undergoing Elective Oocyte Cryopreservation to Prevent Infertility

Verified siteRegistered drugNo placebo
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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 the prevention of female infertility. The study is investigating a method called Random Start Ovarian Stimulation to see how it compares to the traditional method of stimulating the ovaries during the early part of the menstrual cycle. The goal is to determine which method is more effective in preserving eggs for future use. This process is known as Elective Oocyte Cryopreservation, which involves freezing eggs to potentially use them later for pregnancy.

Participants in the study will receive one of the following treatments: Bemfola, which contains the active substance follitropin alfa and is given as an injection under the skin; Duphaston, which contains dydrogesterone and is taken as a tablet by mouth; or Gonapeptyl Daily, which contains triptorelin acetate and is also given as an injection under the skin. Some participants may receive a placebo. The study will last for a period of up to 21 days, during which the effectiveness of these treatments in stimulating the ovaries will be assessed.

The purpose of this study is to find out if the new method of ovarian stimulation is as effective as the traditional method in producing mature eggs that can be frozen. Participants will be monitored throughout the study to track the number of eggs retrieved and the amount of medication used. The study aims to provide valuable information that could help improve fertility preservation techniques for women in the future.

The research process

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

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to sign an informed consent form. This document confirms your understanding of the trial and your agreement to participate.

    You will need to meet certain criteria, such as being between the ages of 25 and 39, having a body mass index (BMI) between 18 and 30, and having a regular menstrual cycle of 24-35 days.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure your eligibility. This may include a review of your medical history and a physical examination to confirm normally accessible ovaries.

  3. Step 3

    Medication administration

    You will begin taking follitropin alfa through a subcutaneous injection using a pre-filled pen. The dosage and frequency will be determined by the study team.

    You will also take dydrogesterone orally in the form of film-coated tablets. The dosage and frequency will be specified by the study team.

    Additionally, triptorelin acetate will be administered via subcutaneous injection. The study team will provide details on the dosage and frequency.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess your response to the medication. This may include blood tests and ultrasound examinations.

    The duration of the ovarian stimulation phase will be tracked, starting from the first day of medication until the application of the trigger for final oocyte maturation.

  5. Step 5

    Oocyte retrieval

    Once the ovarian stimulation phase is complete, the oocytes will be retrieved. The total number of oocytes retrieved and the number of mature cryopreserved oocytes will be recorded.

  6. Step 6

    Completion of trial

    After the oocyte retrieval, your participation in the trial will be complete. The study team will provide any necessary follow-up care and information.

Who can join the trial?

6 criteria

  • Age: You must be between 25 and 39 years old.
  • Body Mass Index (BMI): Your BMI should be between 18 and less than 30. BMI is a measure of body fat based on your weight in relation to your height.
  • Consent: You need to sign a form that shows you understand the study and agree to participate.
  • Menstrual Cycle: Your menstrual cycle should be regular, lasting between 24 to 35 days.
  • Hormonal Contraception: You should not be taking hormonal birth control, or you must have stopped using it at least 2 months ago.
  • Ovaries: Your ovaries should be normally accessible, meaning they can be reached for medical procedures if needed.

Who cannot join the trial?

3 criteria

  • Participants must be **female**.
  • Participants must be within the specified **age range** for the study.
  • Participants should not be part of a **vulnerable population**, which means they should not be in a situation where they might be easily harmed or taken advantage of.
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Investigated drugs

Random Start Ovarian Stimulation is a method used to stimulate the ovaries to produce multiple eggs. This approach allows the stimulation process to begin at any point in the menstrual cycle, rather than waiting for a specific phase. The goal is to collect more eggs for freezing, which can be useful for women who wish to preserve their fertility for future use. This method is being compared to the traditional approach to see if it is just as effective.

What is already known about the treatment

There is no specific medication mentioned in the provided data. Please provide the name of the medication or additional information to proceed with the task.

Investigated diseases

Female Infertility – Female infertility is a condition where a woman is unable to conceive after a year of regular, unprotected intercourse. It can result from various factors affecting the reproductive system, including hormonal imbalances, structural issues with the reproductive organs, or problems with ovulation. The progression of female infertility can vary depending on the underlying cause. For instance, hormonal imbalances may lead to irregular menstrual cycles, while structural issues like blocked fallopian tubes can prevent the egg and sperm from meeting. Over time, if the underlying issues are not addressed, the chances of natural conception may decrease. The condition can be temporary or permanent, depending on the cause and any interventions undertaken.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509919-89-00Estimated enrolment277 patientsSponsorUZ Brussel

sourced from the EU Clinical Trials Register and site verification

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