Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Reproductive outcomes with letrozole co-treatment during ovarian stimulation in women with endometriosis undergoing IVF/ICSI: a randomised, multicentre, parallel group pragmatic trial |
| Participants (P) | Women below the age of 40 years with a surgical or imaging diagnosis of endometriosis (rASRM stages 1- 4) and an indication for IVF/ICSI based on existing guidelines. Patients with and without concomitant adenomyosis will be included. |
| Intervention (I) | Use of letrozole as co-treatment during an ovarian stimulation cycle (i.e an average of 10-12 days) in an GnRH antagonist protocol for IVF/ICSI. Letrozole will be administered 5 mg daily from the start of the ovarian stimulation with gonadotropines until the day of trigger of final oocyte maturation. |
| Control (C) | Standard GnRH antagonist ovarian stimulation protocol with recFSH, without letrozole and without placebo or any other additional medication – or ‘add-ons’. |
| Outcome (O) | Cumulative live birth rate per IVF/ICSI stimulation cycle, including fresh embryo transfer and frozen embryo transfers (of embryos from the same oocyte aspiration) performed within 52 weeks after stimulation start (SD1). |
| Trial Design | Open labelled parallel group multicentre randomized controlled trial in several Belgian fertility centres |
| Sample Size | 854 randomized patients |
| Trial duration | 60 months from FPI to CSR |
| Budget | 2,530,000 € |
Trial team
| Sponsor | UZ Brussel |
| Chief Investigator | Dr Michelle SOARES |
| External partners | |
| Number of participating sites | 11 sites: UZ Brussel |
DOCUMENTS
References
EU Clinical trials: https://clinicaltrials.eu/trial/letrozole-during-ivf-icsi-for-women-with-endometriosis/
Webpage:
Funding scheme
