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Study Comparing Medroxyprogesterone Acetate and Ganirelix for Women Undergoing Fertility Treatment with Embryo Accumulation

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 studying treatments for female infertility. The study will compare two different methods of preparing the body for a procedure called DUOSTIM, which involves stimulating the ovaries to produce multiple eggs. The first method uses a medication called Progevera, which contains the active ingredient medroxyprogesterone acetate. This medication is taken in the form of a tablet. The second method uses a medication called Ganirelix, which is given as an injection under the skin. Both medications are used to help control the body's hormone levels during the treatment process.

The purpose of the study is to determine if there is a difference in the number of healthy embryos that can be obtained using these two different methods. Participants in the study will undergo a process called embryo accumulation, where multiple eggs are collected and fertilized to create embryos. These embryos are then tested to ensure they have the correct number of chromosomes, a process known as PGT-A (Preimplantation Genetic Testing for Aneuploidies). The study will compare the effectiveness of the two methods in producing embryos that are suitable for this testing.

Participants will be divided into two groups, with each group receiving one of the two treatments. The study will last for a period of time during which participants will receive the medication and undergo the necessary procedures. The goal is to see which method results in a higher number of healthy embryos. This information could help improve treatment options for women experiencing infertility.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, menstrual cycle regularity, and the presence of both ovaries.

    Consent is required to participate in the study.

  2. Step 2

    Initial medication administration

    The study involves two different protocols for ovarian stimulation.

    One group receives Progevera (medroxyprogesterone acetate) in the form of a 10 mg tablet taken orally. This medication is used from the start of the ovarian stimulation process.

    The other group receives GANIRELIX via subcutaneous injection. This medication acts as a pituitary suppressor.

  3. Step 3

    Ovarian stimulation

    Ovarian stimulation is conducted to accumulate embryos for genetic testing (PGT-A).

    The process involves double ovarian stimulation, which means the ovaries are stimulated twice to produce more eggs.

  4. Step 4

    Embryo accumulation

    Embryos are accumulated during the ovarian stimulation phase.

    The goal is to obtain a higher number of euploid embryos, which are embryos with the correct number of chromosomes.

  5. Step 5

    Completion of trial

    The trial is estimated to end by June 30, 2025.

    The primary endpoint is the number of euploid embryos obtained.

Who can join the trial?

6 criteria

  • Must be a woman under the age of 43.
  • Must have regular menstrual cycles that last between 21 and 35 days.
  • Must need **IVF** with **PGT-A**. **IVF** stands for **In Vitro Fertilization**, a process where an egg is fertilized by sperm outside the body. **PGT-A** is a test done on embryos to check for the correct number of chromosomes.
  • Must have both ovaries present.
  • Must be able to participate in and complete the study.
  • Must agree to participate and sign a consent form.

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria were provided for this clinical trial.
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Investigated drugs

  • Progestin

    is used in this trial as part of a protocol called Progestin-primed Ovarian Stimulation (PPOS). It is used from the start of ovarian stimulation to help suppress the pituitary gland. This helps in controlling the timing of ovulation and is aimed at improving the chances of obtaining healthy embryos for genetic testing.

  • GnRH Antagonists

    are used in the trial as an alternative method for pituitary suppression. These medications work by blocking the action of natural hormones that stimulate the ovaries, helping to prevent premature ovulation. This method is compared to the use of progestin to see which is more effective in producing healthy embryos for genetic testing.

What is already known about the treatment

  • Progestin

    This medication is administered orally or via injection and is used in protocols for ovarian stimulation. It is currently being studied in clinical trials for its effectiveness in female infertility treatments, specifically in protocols involving embryo accumulation for genetic testing. Progestin works by suppressing the pituitary gland to prevent premature ovulation, allowing for better control over the timing of egg retrieval. It is classified as a hormonal medication, specifically a progestogen, which mimics the effects of natural progesterone in the body.

  • GnRH Antagonists

    These medications are typically administered via injection and are used to prevent premature ovulation during fertility treatments. They are being evaluated in clinical trials for their role in improving outcomes in female infertility, particularly in protocols involving double ovarian stimulation and embryo accumulation. GnRH antagonists work by directly blocking the action of gonadotropin-releasing hormone on the pituitary gland, thereby reducing the release of hormones that trigger ovulation. They belong to the class of medications known as gonadotropin-releasing hormone antagonists.

Investigated diseases

Female infertility – Female infertility is a condition where a woman is unable to conceive after a year of regular, unprotected sexual 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 condition may also be influenced by age, lifestyle, and environmental factors. Infertility can be temporary or permanent, depending on the underlying cause. It often requires a comprehensive evaluation to determine the specific factors contributing to the inability to conceive. Understanding the progression of female infertility involves identifying and addressing these contributing factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508769-33-00Estimated enrolment144 patientsSponsorGinefiv S.L.

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