Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions Undergoing Single Blastocyst-Stage Embryo Transfer: A Randomised Triple-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 792
- 试验地点
- 1
- 主要终点
- Live birth
研究概览
简要总结
This study aims to evaluate the efficacy of atosiban in patients with previous pregnancy failure and abnormal uterine contractions during the peri-embryo transfer period in assisted reproductive technology. The main questions it aims to answer are:
- Does the use of atosiban in patients with a history of implantation failure and abnormal uterine contractions affect the live birth rate in single blastocyst transfer cycles (fresh or frozen-thawed embryo transfer)?
- Evaluate the differences in efficacy of atosiban regarding perinatal complications and neonatal outcomes, as well as differences in safety concerning miscarriage rates and ectopic pregnancy rates.
Researchers will compare atosiban with placebo (a similar substance containing no active medication) to determine whether atosiban is effective in improving live birth rates from single blastocyst transfer cycles (fresh or frozen-thawed embryo transfer) in patients with a history of implantation failure and abnormal uterine contractions.
- Participants allocated to the Atosiban group will be administered Atosiban (37.5 mg/5 mL, Tractocile®, Ferring Pharma, Geneva, Switzerland) as an intravenous (IV) bolus of 6·75 mg/0.9 mL in 1 minute at 30 minutes prior to the ET procedure, followed by an IV infusion at a rate of 18 mg/h for 1 hour; after 1 hour, the dose of Atosiban will be reduced to 6 mg/h, with a total dose of 37.5 mg. Participants allocated to the placebo group will receive identical-looking saline infusions for the same duration.
- One hour post-embryo transfer, all randomized participants will be invited to have a reevaluation of uterine wave patterns via ultrasound, performed by the same examiner.
- Women who had a clinical pregnancy will be subsequently contacted by nurses to document pregnancy events and outcomes at 12 and 24 weeks of gestation, completion of pregnancy, with a follow-up approximately 6 weeks post-delivery. Those participants who had a negative pregnancy test will not be followed up any further as part of this trial.
详细描述
fresh or frozen-thawed embryo transfer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atosiban group
Participants allocated to the Atosiban group will be administered Atosiban
干预措施: Atosiban (Drug)
Placebo group
Participants allocated to the placebo group will receive saline infusions.
干预措施: Placebo Control (Drug)
结局指标
主要结局
Live birth
时间窗: After 24 weeks of gestation
Live birth is defined as the delivery of at least one newborn who exhibits any sign of life.
次要结局
- Biochemical pregnancy(12 days after blastocyst transfer)
- Clinical pregnancy(6-8 weeks after blastocyst transfer.)
- Ongoing pregnancy(After 12 weeks of gestation)
- Miscarriage(before 20 weeks of gestation.)
- Stillbirth(after 20 weeks of gestation)
- Ectopic pregnancy(After 4 to 6 weeks of embryo transfer)
- Multiple pregnancy(7 weeks of gestation)
- Gestational diabetes mellitus(At 28 weeks of pregnancy)
- hypertensive disorders of pregnancy(From 20 weeks of gestation up to at birth)
- preterm birth(At birth)
- low birth weight(At birth)
- Very low birth weight(At birth)
- high birth weight(at birth)
- large for gestational age(at birth)
- small for gestational age(at birth)
- Early neonatal death(within 7days of birth)
- Congenital anomaly(Birth to first year of life)
研究者
He Cai
Principal investigator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi