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临床试验/NCT04501003
NCT04501003Unknown不适用

Investigation of Implantation Markers of Anomalies Classified as U1-A Uterine According to ESHRE/ESGE Classification of Female Genital Tractus Anomalies in Biopsy Specimens Obtained From the Lateral Walls of the Endometrium

Ufuk University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
35
试验地点
1
主要终点
Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.

研究概览

简要总结

Various types and classes of uterine malformations have been identified and the ESHRE / ESGE classification system has recently been published on female genital system anomalies. Postoperative positive pregnancy results were obtained in studies conducted in patients with infertility, recurrent implantation failure, and recurrent pregnancy loss, which were not previously described in T-shaped uterine anomalies. Considering the increase in endometrial gland and vascularity after the surgical procedure performed in these patients, our primary goal in our study is to compare the number of implantation markers (αVβ3 integrin) and subepithelial glands in the specimen biopsies taken from the lateral walls of the endometrium before and after hysteroscopic surgery in patients with class U1a anomalies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Have no systemic disease,
  • •ESGE U1-A having uterine anomaly,
  • •Primary infertile, recurrent implantation loss, recurrent pregnancy loss history,
  • •Not having previous uterine surgery.

排除标准

  • •Patients over the age of 45 under the age of 18,
  • •Those with systemic disease (Hypertension, Heart Disease, Asthma, Renal Disease, Liver Disease, Epilepsy),
  • •Having previous uterine surgery,
  • •Those who gave birth.

研究组 & 干预措施

Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)

Other

With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm.

干预措施: Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen) (Device)

结局指标

主要结局

Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.

时间窗: Baseline

From the endometrium biopsies taken before and after the operation, the implantation marker beta 3 integrin was examined to determine if there was any change in the implantation.

次要结局

未报告次要终点

研究者

发起方
Ufuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sezin Oral Yıldız

Resident

Ufuk University

研究点 (1)

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