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Study on the Effect of Triptorelin Before Frozen Embryo Transfer in Patients with Endometriosis or Adenomyosis

Registered 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 the effects of a treatment for women with endometriosis and/or adenomyosis. These are conditions where tissue similar to the lining inside the uterus grows outside of it, causing pain and other symptoms. The treatment being tested is a medication called triptorelin, which is a type of drug known as a GnRH agonist. This medication is given as a prolonged-release injection, meaning it is designed to release slowly over time to provide long-lasting effects.

The purpose of the study is to see if using triptorelin before a procedure called frozen embryo transfer (FET) can improve pregnancy rates in women undergoing assisted reproductive technology (ART). In this study, some participants will receive the triptorelin treatment, while others will receive a placebo. The study will monitor the clinical pregnancy rates, which means checking for a fetal heartbeat during an ultrasound at the final visit.

Participants will be followed throughout the study to observe the number of successful embryo implantations, any miscarriages, and any side effects related to low estrogen levels, such as hot flashes or mood swings. The study aims to provide valuable information on whether this treatment can help improve outcomes for women with endometriosis and/or adenomyosis who are trying to conceive through ART.

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

    Joining the study

    Eligibility is confirmed based on criteria such as age, medical condition, and previous treatments.

    An MRI with contrast injection is required to confirm endometriosis and/or adenomyosis if no recent results are available.

    Consent form is signed, and health insurance affiliation is verified.

  2. Step 2

    Medication administration

    The medication used is triptorelin, administered as a prolonged-release suspension for injection.

    The product name is DECAPEPTYL L.P. 11,25 mg, and it is injected either intramuscularly (IM) or subcutaneously (SC).

    This injection is designed to release the medication over a period of three months.

  3. Step 3

    Frozen embryo transfer preparation

    The purpose of the medication is to prepare the body for a frozen embryo transfer (FET).

    The impact of the medication on clinical pregnancy rates is assessed as part of the study.

  4. Step 4

    Monitoring and evaluation

    The primary evaluation criterion is the clinical pregnancy rate, confirmed by the presence of a fetal heartbeat during an ultrasound at the final visit.

    Secondary evaluations include the number of successful implantations, incidence of miscarriage, and side effects related to low estrogen levels.

Who can join the trial?

6 criteria

  • Women aged 18 to 36 with endometriosis and/or adenomyosis. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it. Adenomyosis is when this tissue grows into the muscular wall of the uterus.
  • Have undergone IVF/ICSI with freeze-all, and a blastocyst FET is planned. IVF/ICSI refers to in vitro fertilization/intracytoplasmic sperm injection, which are methods to help with pregnancy. A blastocyst FET means transferring a fertilized egg that has been frozen and is at a specific stage of development.
  • A normal uterine cavity. This means the inside of the uterus is healthy and has no abnormalities.
  • An MRI with contrast injection confirming endometriosis and/or adenomyosis during the inclusion visit. MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body. The contrast injection helps to see the tissues more clearly.
  • Having signed a consent form. This means agreeing to participate in the study after understanding what it involves.
  • Affiliated with a health insurance plan. This means having health insurance coverage.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of endometriosis or adenomyosis cannot participate. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it. Adenomyosis is when this tissue grows into the muscular wall of the uterus.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are considered part of a vulnerable population are not eligible. A vulnerable population might include groups like children or those unable to give consent.
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Investigated drugs

GnRH Agonist is a medication used in this study to help improve pregnancy rates in patients undergoing frozen embryo transfer. It works by temporarily suppressing the body's natural hormone production, which can help create a more favorable environment for embryo implantation, especially in patients with conditions like endometriosis or adenomyosis.

What is already known about the treatment

GnRH Agonist – This medication is administered as an injection and is currently being studied for its potential benefits in assisted reproductive technology, particularly for patients with endometriosis and adenomyosis. It is used to improve clinical pregnancy rates by regulating hormone levels before frozen embryo transfer. The GnRH agonist works by initially stimulating and then suppressing the release of certain hormones from the pituitary gland, which helps in managing conditions like endometriosis. It is classified as a gonadotropin-releasing hormone agonist in pharmacology.

Investigated diseases

  • Endometriosis

    A condition where tissue similar to the lining inside the uterus grows outside the uterus, often on the ovaries, fallopian tubes, and pelvic lining. This tissue behaves like normal uterine tissue, thickening and breaking down with each menstrual cycle, but it has no way to exit the body. This can lead to inflammation, pain, and the formation of scar tissue. Over time, endometriosis can cause severe menstrual cramps, chronic pain, and fertility issues. The severity of symptoms can vary widely among individuals.

  • Adenomyosis

    A condition where the inner lining of the uterus breaks through the muscle wall of the uterus. This can cause the uterus to become enlarged and lead to heavy, painful periods. The condition is often associated with menstrual cramps and pelvic pain. Over time, adenomyosis can result in chronic pelvic pain and discomfort. The symptoms can vary in intensity and may worsen with age.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519126-20-00Protocol code2019_0012Estimated enrolment180 patientsSponsorHospital Foch

sourced from the EU Clinical Trials Register and site verification

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