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

Condition studied

Women with endometriosis undergoing IVF/ICSI

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

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)