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临床试验/NCT03470298
NCT03470298Unknown不适用

Retrieval Endometrial Scratching Versus Mid-luteal Endometrial Scratching for Women Undergoing ICSI for Unexplained Infertility

Mansoura University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Live birth rate

研究概览

简要总结

ES is a procedure used to help embryos to implant more successfully after In-Vitro Fertilization (IVF) , ICSI in patients who had failed cycles in spite of transfer of good quality embryos. New researches and evidence suggests that scratching the uterine endometrium causes a repair reaction in patients may increase embryo implantation rate . In spit of the optimum timing of scratching not finally determined, the usual timing to perform ES is approximately one week before starting IVF, ICSI treatment . our study aims to compare other time of scratching which is the scratching at retrieval time.

详细描述

Endometrial scratching (ES) is a procedure used to help embryos to implant more successfully after In-Vitro Fertilization (IVF), ICSI in patients who had failed cycles in spite of transfer of good quality embryos. New researches and evidence suggests that scratching the uterine endometrium causes a repair reaction in patients may increase embryo implantation rate. The usual timing to perform ES is approximately one week before starting IVF, ICSI treatment.

Aim:

Comparing results of performing endometrial scratching one week before starting ICSI cycle treatment and at day of oocyte retrieval.

Material &Methods :

This is a prospective clinical trial, involving patients undergoing ICSI treatment at fertility care unite, Mansoura University Hospital and private fertility centers. The subjects were recruited from the period between January 2017 and June 2018. An informed consent obtained. Sample size was calculated using Graph Pad Inset soft were, version 3.01.Twenty four patient in each group were required to give the study a power of 80% and α of 0.05. Good responders were defined as the patients who had develop, at least four good-quality embryos grade 1 and 2 of Veeck's grading in the previous IVF cycle. Patients found eligible for the study were offered to undergo endometrial scratch-suction either in The usual timing to perform ES is approximately one week before starting IVF, ICSI treatment, the other at the time of oocyte retrieval, just after finishing oocyte pickup.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with at least one previous failed ICSI cycles, Good responders in the previous ICSI cycle and Less than or equal to 35 years

排除标准

  • . We excluded patients with; Presence of intramural fibroid distorting the endometrial cavity/sub mucous myoma/a Sherman's syndrome, Presence of son graphically detected hydrosalpinx, Patient age more than 35 years

研究组 & 干预措施

Mid luteal Endometrial Scratching (MLES)

Active Comparator

Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 . At this arm scratching done at mid luteal phase (day21) of the cycle before induction for ICSI

干预措施: Endometrial scratching (Procedure)

Retrieval Endometrial Scratching (RES)

Active Comparator

Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 .Here scratching done at same day of ovum pick up of ICSI cycle the difference only between arm of MLES and RES only in the timing of scratching .

干预措施: Endometrial scratching (Procedure)

结局指标

主要结局

Live birth rate

时间窗: about 9 months

delivery of a fetus after passing medico legal viability

次要结局

  • implantation rate(2 weeks after embryo transfer)
  • Clinical pregnancy rate(4 weeks after embryo transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abd Elhady Zayed

Associate professor of Obstetrics &Gynecology

Mansoura University

研究点 (1)

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