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临床试验/NCT04888091
NCT04888091已完成不适用

The Effect of Two Different Cervical Mucus Removal Methods on Pregnancy Rates. 180 Cases Will be Randomized Into 3 Groups for Cervical Mucus Intervention. Removal With Cotton Swab, Removal With Cannula and Mucus Left on Cervix.

Zeynep Kamil Maternity and Pediatric Research and Training Hospital2 个研究点 分布在 2 个国家目标入组 183 人开始时间: 2021年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
183
试验地点
2
主要终点
Detecting pregnancy after embryo transfer.

研究概览

简要总结

To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.

详细描述

All patients will be informed about the study and those who give written consent will be included in the study.

Women undergoing good quality embryo transfer will be assigned to one of the 3 arms of the study according to the previously determined randomization chart. The first evaluation of the patient will be made on the 12th day after embryo transfer. Pregnancy status will be evaluated with serum βhcg value. If pregnancy is confirmed by serum βhcg value, fetal viability will be evaluated by ultrasound 4 weeks after 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
Single (Participant)

盲法说明

Participant masking: Embryo transfer is done while the patient is lying in lithotomy position in accordance with gynecological examination. The patient is informed about the preparations before the embryo transfer and then the examination is completed. The patient will not be informed about the method used for removal of the cervical mucus. The patient's lying position also does not allow observation of the material used to remove cervical mucus.

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 21-40 years old women,
  • Women undergoing good quality embryo transfer,
  • Women who are eligible for a single or double embryo transfer.

排除标准

  • If there is a diagnosis of a uterine anomaly,
  • If there is a diagnosis of myoma uteri,
  • If there is a diagnosis of rheumatological disease,
  • Women to be transferred other than good quality embryo,
  • Hİstory of previous pelvic, gynecological operation.

研究组 & 干预措施

No cervical mucus removal

No Intervention

Cervical mucus will not be removed prior to embryo transfer

Cervical mucus removal with cotton swab

Active Comparator

Cervical mucus will be removed with cotton swab before embryo transfer

干预措施: Cotton swab (Procedure)

Cervical mucus removal with cannula

Active Comparator

Cervical mucus will be removed with cannula before embryo transfer

干预措施: Cannula (Procedure)

结局指标

主要结局

Detecting pregnancy after embryo transfer.

时间窗: 12 days after embryo transfer/ intervention.

Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.

Confirmation of fetal cardiac activity in detected pregnancy.

时间窗: 3-4 weeks after embryo transfer/ intervention.

Evaluation of fetal cardiac activity on ultrasound.

次要结局

  • Success of embryo transfer during intervention.(5 minutes after embryo transfer.)

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

enis ozkaya

Associate Professor, Specialist in Obstetrics and Gynecology

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (2)

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