Letrozole During IVF/ICSI for Women with Endometriosis

1 1 1 1

What is this study about?

This study is being done in women with endometriosis who are undergoing IVF/ICSI, which are fertility treatments using eggs, sperm, and embryos outside the body. The treatment being studied is letrozole, a medicine taken by mouth during ovarian stimulation, the part of treatment when the ovaries are helped to produce eggs. The purpose of the study is to find out whether adding letrozole during this part of treatment can improve the chance of a live birth after embryo transfer.

In the study, one group receives letrozole together with the usual fertility treatment, while the other group receives the usual treatment without letrozole. Treatment is given during one egg collection cycle, and any embryos made from that cycle may be transferred fresh or frozen and used later within about one year. The study then follows the pregnancy outcomes after these embryo transfers. The study also looks at related conditions such as adenomyosis, a condition in which tissue similar to the lining of the womb grows into the womb muscle.

The study is designed to see whether letrozole can improve reproductive results in this setting and to collect information on pregnancy, birth, and any problems that may happen during pregnancy. It also records pain after egg collection and quality of life around the time of embryo transfer.

Who Can Join the Study?

  • Women who are subfertile or infertile, meaning they have difficulty becoming pregnant, and who have a diagnosis of endometriosis of any type or stage.
  • The diagnosis of endometriosis must have been made by transvaginal ultrasound (TVUS), MRI (magnetic resonance imaging), or surgery.
  • They must already have a medical reason to undergo IVF/ICSI, which are fertility treatments where eggs are collected and fertilized outside the body, with ICSI meaning a single sperm is injected directly into an egg.
  • A fresh embryo transfer must be planned after egg retrieval, meaning an embryo will be placed into the uterus soon after the eggs are collected.
  • Women with or without adenomyosis may take part; adenomyosis means tissue similar to the lining of the uterus grows into the muscle wall of the uterus.
  • They must have had no more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy, including attempts that led to fresh or frozen embryo transfers.
  • They must be between 18 and 39 years old.
  • Their body mass index (BMI) must be less than 35 kg/m²; BMI is a measure of body weight compared with height.
  • They must be able to give informed consent, meaning they can understand the study and agree to join it on their own.
  • Each patient can take part in the study only once.

Who Cannot Join the Study?

  • Anti-Müllerian hormone (AMH) level below 0.5 ng/mL in the year before randomization. AMH is a blood test that helps estimate ovarian reserve, meaning how many eggs may remain in the ovaries.
  • An abnormal uterine cavity, such as a Müllerian duct anomaly (a birth-related difference in the shape of the uterus), intra-uterine adhesions (scar tissue inside the uterus), or any other untreated problem inside the uterus.
  • Untreated tubal factor, specifically hydrosalpinx. Hydrosalpinx means a fallopian tube is blocked and filled with fluid.
  • Any untreated endocrine abnormality. Endocrine means hormone-related, so this includes any hormone problem that has not been treated.
  • If sperm must be obtained by surgery, which means surgically obtained sperm.
  • If ovarian stimulation is being done for pre-implantation genetic testing (PGT-A/M). This is testing embryos for chromosome problems or specific genetic diseases before transfer.
  • A history of severe ovarian hyperstimulation syndrome (OHSS) in a previous treatment cycle, or if the patient is already planned to follow a freeze-all strategy. OHSS is a serious reaction where the ovaries become overstimulated during fertility treatment; a freeze-all strategy means all embryos are frozen instead of being transferred right away.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
CHC MontLegia Liege Belgium
Ziekenhuis Oost Limburg Genk Belgium
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Vrije Universiteit Brussel Jette Belgium
Cfleqrqyu Uybkxagdnakpri Sscipzdfx Woluwe-Saint-Lambert Belgium
Uwtzdfxbxc Oq Aedtuzr Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.06.2026

Trial locations

Investigated drugs:

Letrozole is the study medicine being tested in this trial. It is taken by mouth during ovarian stimulation as part of IVF/ICSI treatment. The goal is to see whether adding letrozole can help improve the chance of a live birth after embryo transfer in women with endometriosis, with or without adenomyosis. It is being used alongside the usual fertility treatment, not as a stand-alone treatment.

Investigated diseases:

Endometriosis – Endometriosis is a condition in which tissue similar to the lining inside the uterus grows outside the uterus. It often causes ongoing pelvic pain and may be linked to heavy or painful periods. The tissue can respond to monthly hormone changes, so symptoms may come and go over time. In some people, it can lead to scarring and changes in nearby organs.

Trial ID:
2025-524995-53-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study testing vipoglanstat for women with moderate to severe endometriosis-related pain

    Recruiting

    Investigated drugs:
    Bulgaria Czechia Hungary Italy Poland Romania
  • Study on Using Fluoroestradiol F-18 PET/CT for Detecting Endometriosis in Patients with Pain

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France