Effect of Hysteroscopic Isthmocele Repair on IVF Outcome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of Clinical pregnancy
研究概览
简要总结
Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.
Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer will be assed for study eligibility. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome.
详细描述
Hysteroscopic Isthmocele repair on IVF outcome Background: Uterine niche is a very common finding in women with previous caesarean section. Subfertility can be associated finding and IVF outcome can be affected by its presence. It is not yet if its treatment before IVF trial could improve the outcome of IVF cycle.
Objectives: assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.
Methods This prospective randomized controled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Seconday outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.
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
- None
盲法说明
The allocated groups will be concealed in serially-numbered sealed opaque envelops that was only opened just after recruitment. Women in any of the groups will receive the allocated treatment after their approval to participate in the study.
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed CS scar defect by TVUS
- •At least one failed trial of euploid embryo transfer
- •Planning for a trial of single euploid embryo transfer
排除标准
- •Residual myometrial thickness less than 3 mm
- •Any congenital uterine abnormalities.,
- •Prescence of intrauterine lesions e.g. polyp, fibroid, Endometriosis or adenomyosis, Hydrosalpinx, Chronic endometritis, Previous CS scar defect repair.
结局指标
主要结局
Rate of Clinical pregnancy
时间窗: at 7 weeks of gestation or beyond
detection of intrauterine pregnancy with a detectable fetal heart pulsation by transvaginal ultrasound scan
次要结局
- Rate of Complications following hysteroscopic CS scar repair(up to 6 weeks)
- Rate of Need of aspiration of intrauterine fluid(During the preparation of embryo transfer. Through study completion, an average of 1 year)
- Rate of Early pregnancy complications(12 weeks gestation)
- Rate of delivery of a living baby(Within 40 weeks of pregnancy)
- Rate of Caesarean section scar dehiscence or rupture(Within 40 weeks of pregnancy)
研究者
Ahmed Elsayed Hassan Hamed Elbohoty
Reproductive medicine consultant
HealthPlus Fertility Center