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Study of leuprorelin and progestogen treatment in women with adenomyosis undergoing assisted reproductive technology to improve pregnancy outcomes

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 study focuses on women with adenomyosis, a condition where tissue that normally lines the uterus grows into the muscular wall of the uterus, and its impact on fertility treatments. The research compares outcomes in women who have adenomyosis to those who don't but have similar fertility challenges. The study uses leuprorelin acetate, a hormone medication given by injection, and an oral medication that belongs to the group of progestogens.

The main purpose is to determine how successful fertility treatments, specifically Assisted Reproductive Technology (ART), are in achieving live births in women with adenomyosis compared to those without the condition. The study examines different treatment protocols and their effects on pregnancy outcomes.

During the study, participants will receive either leuprorelin acetate through injection (up to 3 mg daily) or progestogen medication taken by mouth (up to 4 mg daily). The treatment protocols will be either "long" or "ultra-long" and will include monitoring of pregnancy progress and outcomes. The research will also look at various factors that might affect treatment success, including how the body's immune system responds to the treatments.

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

    Initial diagnosis confirmation

    A transvaginal ultrasound will be performed to confirm the presence or absence of adenomyosis (a condition where tissue similar to the uterine lining grows into the uterine wall)

    Your eligibility will be verified based on specific criteria, including age (between 18 and 42 years) and body mass index (BMI less than 30)

  2. Step 2

    Treatment group assignment

    You will be randomly assigned to one of the treatment protocols: either a long protocol or an ultra-long protocol

    Both protocols include dienogest, a medication that helps reduce inflammation

  3. Step 3

    Medication administration

    Leuprorelin acetate will be administered through injection

    Additional medications will be given orally as part of the fertility treatment

  4. Step 4

    Fertility treatment

    You will undergo controlled ovarian stimulation as part of the fertility treatment

    This will be followed by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)

    This will be either your first or second IVF/ICSI attempt

  5. Step 5

    Monitoring and follow-up

    Regular monitoring will continue throughout the pregnancy if successful

    The study will track outcomes including pregnancy progress and birth outcomes

    Blood samples may be collected for laboratory analysis of immune system markers

Who can join the trial?

9 criteria

  • Women must have either a diagnosis of adenomyosis (a condition where the inner lining of the uterus grows into the uterine wall) confirmed by transvaginal ultrasound, or be without adenomyosis but have similar reproductive risk factors
  • Must be between 18 and 42 years of age
  • Must have a body mass index (BMI) below 30
  • Must be undergoing their first or second IVF/ICSI attempt (fertility treatments where eggs are fertilized in a laboratory)
  • Must have adequate ovarian function, shown by:
    • Antral follicle count of 8 or more (number of potential egg-containing follicles)
    • AMH level of 1 ng/ml or higher (a hormone that indicates egg reserve)
    • Must be in good physical and mental health, with no medical conditions that would prevent IVF treatment
    • Must meet the Italian legal requirements for assisted reproductive technology (ART) treatment
    • Both partners must be willing to provide written informed consent

Who cannot join the trial?

10 criteria

  • Age below 18 or above 45 years
  • Male patients (study is for females only)
  • No confirmed diagnosis of adenomyosis (a condition where the inner lining of the uterus grows into the uterine wall) through transvaginal ultrasound (an internal ultrasound examination)
  • Not seeking fertility treatment or Assisted Reproductive Technology (ART) (medical procedures used to help achieve pregnancy)
  • Current pregnancy
  • Inability to provide informed consent
  • Participation in other clinical trials
  • Medical conditions that could interfere with fertility treatment
  • History of severe allergic reactions to fertility medications
  • Presence of other significant uterine conditions that could affect the study results
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Investigated drugs

Leuprolide is an injectable medication that temporarily suppresses the body’s natural hormone signals that control the ovaries. By turning off this signal, doctors can better manage the ovarian stimulation process used in assisted reproductive technology, helping to synchronize the development of eggs and improve the chances of a successful pregnancy.

What is already known about the treatment

  • Leuprorelin

    This medication is given as a short injection under the skin. It is an approved drug that is widely used in medical practice and described in many studies. It is mainly used to control hormone‑dependent conditions such as endometriosis, certain cancers, and to help regulate ovarian stimulation in assisted reproduction. Leuprorelin works by first stimulating and then shutting down the pituitary gland’s release of hormones, which lowers the levels of estrogen and other sex hormones; it belongs to the class of GnRH (gonadotropin‑releasing hormone) agonists.

  • Progesterone

    This medication is taken as an oral tablet. It is a well‑known, approved hormone that has been studied extensively and is listed in medical guidelines. It is mainly used to support the uterine lining in women undergoing assisted reproduction and to treat hormonal imbalances. Progesterone works by binding to specific receptors in the uterus and other tissues, mimicking the natural hormone’s actions to prepare the body for pregnancy; it is classified as a synthetic progestogen.

Investigated diseases

Adenomyosis - A condition where the inner lining of the uterus (endometrial tissue) grows into the muscular wall of the uterus. The displaced tissue continues to function normally during each menstrual cycle, causing the uterus to become enlarged and thickened. This condition typically develops in women during their reproductive years. Women with adenomyosis may experience heavy menstrual bleeding, painful periods, and pelvic discomfort. The condition can affect fertility and pregnancy outcomes in some cases.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516089-12-00Protocol codeADENOFERTEstimated enrolment500 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

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