Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 858
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.
详细描述
The single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of Embryo Transfer (ET). This randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. The allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. Given the intrinsic viscous nature of EmbryoGlue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. Only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cycles with single blastocyst transfer will be considered eligible
- •Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
- •No age restriction will be applied
- •Informed consent was signed
排除标准
- •Uterine anatomic anomalies
- •Women with untreated hydrosalpines
- •Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.
研究组 & 干预措施
Hyaluronic Acid(EmbryoGlue®)
High HA concentrations (0.5 mg/ml)
干预措施: High Hyaluronic Acid concentrations (0.5 mg/ml) (Biological)
Hyaluronic Acid (G2 medium)
Low HA concentrations (0.125 mg/ml)
干预措施: Low Hyaluronic Acid concentrations (0.125 mg/ml) (Biological)
结局指标
主要结局
Live birth rate
时间窗: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.
The primary outcome was Live birth rate per embryo transfer.
次要结局
- Biochemical pregnancy(12 days after embryo transfer.)
- Clinical pregnancy(6-8 weeks after embryo transfer)
- Ongoing pregnancy(after 12 weeks of gestation.)
- Miscarriage(20 weeks of gestation.)
- Ectopic pregnancy(After 4 to 6 weeks of embryo transfer)
- Multiple pregnancy(7 weeks of gestation.)
- hypertensive disorders in pregnancy(From 20 weeks of gestation up to at birth)
- Placental implantation disorders(From 20 weeks of gestation up to at birth)
- Preterm birth(At birth)
- Preterm premature rupture of membranes(Before 37 weeks of gestation and before the onset of labor)
- Mode of delivery(At birth)
- Gestational age(At birth)
- Birth weight(At birth)
- low birth weight(At birth)
- Very low birth weight(At birth)
- Mean birth weight(1 year after embryo transfer)
- Macrosomia(At birth)
- Large for gestational age(At birth)
- Small for gestational age(At birth)
- Neonatal intensive care unit admission(Birth up to 1 year)
- Stillbirth or late fetal death(At birth)
- Congenital anomaly or birth defect(Birth to first year of life)
- Early neonatal death(Up to 28 days after birth)
研究者
He Cai
Principal Investigator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi