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临床试验/NCT06619379
NCT06619379进行中(未招募)不适用

The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During The Embryo Transfer Process

Eurofertil IVF Health Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Pregnacy rates

研究概览

简要总结

Investigators aim to investigate possible affects of a speculum material and retention strategy on IVF pregnancy results. The study is planned as a prospective, randomized control trial. All of the clinical managements, including the embryo transfers, will be performed by the same gynecologist for homogeneity of the study. Only the cases with good implantation potentials are going to be included. Therefore, transfers with cleavage embryos and blastocysts rather than good and top quality will be excluded. All patients included to final statistical analysis will receive the same luteal support.

详细描述

Participants will be included among the 20 - 40 years old women applying to for IVF. Women with mullerian anomalies and couples with chromosomal abnormalities will be excluded. Histrory of recurrent implantation failure, thin endometrium will also be considered as exclusion criterias. Participants who are initially included in the study will be excluded either the demanded preimplantation genetik testing for aneuploidy optionally, or if the embryo transfer is performed under general anesthesia or the embryo transfer is recorded as difficult transfer.

The participants included in the study will be randomised for the speculum material ( metal or plastic) and also for the retention time of the speculum out of the vagina. Just immediately before applying the speculum to the patient, the material temperature will be measured and recorded with a thermometer capable of digital and object measurement.

All of the transfers will be performed with the same technique. After the embryo transfer is made and the transfer catheter is withdrawn, the speculum will be extracted according to the randomization. If the speculum is not extracted immediately, the chronometer will be started and the extraction will be done either in the 60. second or 420. second ( 7 minutes) according to the randomization . As there are two speculum materials and three retention time arms in the design, a total of 6 groups will be formed after crossover. Data gained in this way will be analyzed and their demographic data and embryological parameters will be evaluated and the implantation rates, pregnancy rates and clinical pregnancy rates of the patients will be determined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • women aged 20-40
  • cases that good and top quality embryos are achieved for embryo trasnfer

排除标准

  • recurrent implantation failure
  • any known genetic problems of couple
  • any known mullein anomalies
  • PGT-A cases
  • thin endometrium

结局指标

主要结局

Pregnacy rates

时间窗: Beta-HCG test will be taken on the 12th day of the embryo transfer

Pregnancy rates is the primary outcome

次要结局

未报告次要终点

研究者

发起方
Eurofertil IVF Health Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Güler Ergin

MD, Embryologist

Eurofertil IVF Health Center

研究点 (1)

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