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

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What is this study about?

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.

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 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 Medication administration

Leuprorelin acetate will be administered through injection

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

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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Alamops Uqy Iybtk Du Rygxsu Emzprr	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	16.01.2023

Trial locations

Investigated drugs:

Leuprorelin Acetate

Based on the provided trial information about assisted reproductive technology (ART) in women with adenomyosis, this appears to be an observational study comparing outcomes between different groups rather than testing specific medications. The trial focuses on comparing pregnancy outcomes in women undergoing standard ART procedures, and no specific medications are mentioned in the source data to list or describe.

If any medications were involved in the standard ART protocols, they are not specified in the provided data, so I cannot list or describe them accurately.

The study appears to be comparing outcomes between women with and without adenomyosis who are undergoing fertility treatments, but specific medications or therapies are not detailed in the source information.

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.

Note: The source data mentions two groups – women with and without adenomyosis, but since only adenomyosis is the actual medical condition being studied, I’ve provided description for just that condition.

Trial ID:

2024-516089-12-00

Protocol code:

ADENOFERT

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?