ENDO-REAL: Endometriosis and Reproductive Enhancement with Letrozole
Key facts
- Where
- Anderlecht, Antwerp, Brugge, Edegem, Genk, Gent, Jette, Leuven, Liège és Sint-Lambrechts-Woluwe, BelgiumSee the 11 sites
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Belgium
- Hopital ErasmeAnderlecht, BelgiumTaking people
- Ziekenhuis Aan De StroomAntwerp, BelgiumTaking people
- AZ ST-JAN Brugge A.V.Brugge, BelgiumTaking people
- Universitair Ziekenhuis AntwerpenEdegem, BelgiumTaking people
- Ziekenhuis Oost-LimburgGenk, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- UZ BrusselJette, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- Centre Hospitalier Regional de la CitadelleLiège, BelgiumTaking people
- CHC MontLégiaLiège, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Brussel
- Trial code
- EU 2025-524995-53-00
- Record updated
- 2026. augusztus 25.
- Original description
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.Read full original descriptionShow less
Reproductive outcomes with letrozole co-treatment during ovarian stimulation in women with endometriosis undergoing IVF/ICSI: a randomised, multicentre, parallel group pragmatic trial
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.
Inclusion: 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.
Exclusion: Severe OHSS in previous treatment cycle or patients planned in forehand for a freeze-all strategy; 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).