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Reproductive outcomes with letrozole co-treatment during ovarian stimulation in women with endometriosis undergoing IVF/ICSI: a randomised, multicentre, parallel group pragmatic trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524995-53-00
Enrollment
854
Registered
2026-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with endometriosis undergoing IVF/ICSI

Brief summary

The primary endpoint is cumulative live birth per stimulation (or IVF/ICSI) cycle, including fresh ET and frozen ETs resulting from the same oocyte aspiration and transferred within 1 year of randomization.

Detailed description

LBR per fresh ET cycle (excluding freeze-all), defined as live birth at ≥ 24 weeks of gestation., Number of ETs needed for successful pregnancy, Miscarriage rate (defined as pregnancy loss prior to viability scan and including those confirmed on ultrasound scan up to ≤ 23 weeks 6 days gestation) for fresh and frozen ETs., Implantation rate (positive serum βhCG 10-15 days after transfer) for fresh and frozen ETs., Clinical pregnancy rate (at least one gestational sac 4-6 weeks after transfer) for fresh and frozen ETs., Rate of ectopic pregnancy or pregnancy of unknown location for fresh and frozen ETs., For women achieving a pregnancy > 24 weeks:  Pregnancy related complications: pre-eclampsia and pregnancy-induced hypertension, preterm birth, intrauterine growth restriction, caesarean delivery and obstetric hemorrhage.  Extreme preterm birth (24-28 weeks of gestation)  Still birth and termination of pregnancy  Gestational age at delivery, Birthweight  Neonatal admission and mortality  Major congenital abnormalities, Pain score: NRS 1-10 one to four hours after OPU, Patient QOL measured at the day of fresh embryo transfer (OPU +5) and compared to baseline (FertiQOL)

Interventions

DRUGLetrozole Teva 2

Sponsors

UZ Brussel
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint is cumulative live birth per stimulation (or IVF/ICSI) cycle, including fresh ET and frozen ETs resulting from the same oocyte aspiration and transferred within 1 year of randomization.

Secondary

MeasureTime frame
LBR per fresh ET cycle (excluding freeze-all), defined as live birth at ≥ 24 weeks of gestation., Number of ETs needed for successful pregnancy, Miscarriage rate (defined as pregnancy loss prior to viability scan and including those confirmed on ultrasound scan up to ≤ 23 weeks 6 days gestation) for fresh and frozen ETs., Implantation rate (positive serum βhCG 10-15 days after transfer) for fresh and frozen ETs., Clinical pregnancy rate (at least one gestational sac 4-6 weeks after transfer) for fresh and frozen ETs., Rate of ectopic pregnancy or pregnancy of unknown location for fresh and frozen ETs., For women achieving a pregnancy > 24 weeks:  Pregnancy related complications: pre-eclampsia and pregnancy-induced hypertension, preterm birth, intrauterine growth restriction, caesarean delivery and obstetric hemorrhage.  Extreme preterm birth (24-28 weeks of gestation)  Still birth and termination of pregnancy  Gestational age at delivery, Birthweight  Neonatal admission and mor

Outcome results

None listed

Source: EU CTIS · Data processed: May 14, 2026