Women with endometriosis undergoing IVF/ICSI
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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 | — |