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ENDO-REAL: Endometriosis and Reproductive Enhancement with Letrozole
EU CTIS ID: 2025-524995-53-00
What this study is testing
The primary objective of this study is to determine whether letrozole co-administration during ovarian stimulation for IVF/ICSI can improve the occurrence of a live birth following embryo transfer(s) in patients diagnosed with endometriosis +/- adenomyosis. Primary outcome will focus on cumulative live birth per stimulation cycle, including fresh and frozen embryo transfers resulting from the same oocyte aspiration and transferred within 1 year (52 weeks) of randomization. Live birth following fresh embryo transfer and number of ETs needed for successful pregnancy will also be evaluated as an important outcome.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sub/infertile women with a diagnosis of endometriosis (all types/ stages) either by TVUS/ MRI or surgically and an indication for treatment with IVF/ICSI (based on existing guidelines) are eligible for the study.
- Planned fresh ET following oocyte retrieval
- Patient with and without concomitant adenomyosis will be included
- The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts). Each patient may only participate once.
- Age ≥ 18 years and < 40 years
- Body mass Index (BMI) < 35kg/m
You likely can't join if
- Anti-müllerian hormone (AMH) < 0.5 ng/mL (dosage in the 1 year preceding randomization)
- Abnormal uterine cavity (known mullerian duct anomalies, intra-uterine adhesions or other untreated intra-uterine pathology)
- Untreated tubal factor (hydrosalpinx)
- Any untreated endocrine abnormality
- Surgically obtained sperm
- Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
See the full eligibility criteria
- Sub/infertile women with a diagnosis of endometriosis (all types/ stages) either by TVUS/ MRI or surgically and an indication for treatment with IVF/ICSI (based on existing guidelines) are eligible for the study.
- Planned fresh ET following oocyte retrieval
- Patient with and without concomitant adenomyosis will be included
- The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts). Each patient may only participate once.
- Age ≥ 18 years and < 40 years
- Body mass Index (BMI) < 35kg/m
- Participant should be capable of giving informed consent
- Anti-müllerian hormone (AMH) < 0.5 ng/mL (dosage in the 1 year preceding randomization)
- Abnormal uterine cavity (known mullerian duct anomalies, intra-uterine adhesions or other untreated intra-uterine pathology)
- Untreated tubal factor (hydrosalpinx)
- Any untreated endocrine abnormality
- Surgically obtained sperm
- Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
- Severe OHSS in previous treatment cycle or patients planned in forehand for a freeze-all strategy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.