Reproductive outcomes with letrozole co-treatment during ovarian stimulation in women with endometriosis undergoing IVF/ICSI: a randomised, multicentre, parallel group pragmatic trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Brussel
- 入组人数
- 854
- 试验地点
- 11
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Severe OHSS in previous treatment cycle or patients planned in forehand for a freeze-all strategy
研究组 & 干预措施
Letrozole Teva 2,5 mg filmomhulde tabletten
干预措施: Letrozole Teva 2,5 mg filmomhulde tabletten (Drug)
结局指标
主要结局
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.
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.
次要结局
- 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)
研究者
Michelle Soares
Scientific
UZ Brussel