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临床试验/NCT04233983
NCT04233983Unknown不适用

Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve

Uludag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Positive b-hCG Rate

研究概览

简要总结

This prospective study evaluates the pregnancy results after laparoscopic endometriosis operation in infertile patients with ERROR (endometrioma related reduction in ovarian reserve)

详细描述

This study consists of two groups. Patients will be randomly enrolled into the groups by ART (assisted reproductive technology) centre nursery. All patients will sign a consent form about procedure.

Patients diagnosed with endometrioma (larger than 3 cm diameter) and ERROR (endometrioma related reduction in ovarian reserve - Antimullerian Hormon < 1.2 ng/ml, Antral follicle count < 7 , Day3 Follicle Stimulating Hormone > 10 IU/dl, Low response to ovarian hyper stimulation < 3 oocytes) will be enrolled in study. Patients with age >40, with male factor, with undefined adnexal mass, malignity suspicion will be excluded from study.

The study group consists of patients who will undergo laparoscopic endometriosis surgery after ICSI procedure with freezing all embryos. The patients will wait about 6 months for spontaneous conception, if there is no pregnancy during this period, frozen embryo transfer will be performed. The control group consists of patients who will be performed IVF&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then.

As the primary; result positive b-hCG rates will be compared between groups.

In conclusion we will find out whether laparoscopic endometriosis operation improves or worsens the pregnancy results in patients with ERROR.

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

入排标准

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

入选标准

  • Presence of Endometrioma at least in one ovary, larger than 3 cm diameter
  • Endometriosis Related Reduction in Ovarian Reserve (ERROR)
  • Presence of endometriosis related infertility

排除标准

  • Presence of chronic systemic disease
  • Presence of male factor infertility
  • Suspicion of ovarian malignancy or undefined ovarian mass

结局指标

主要结局

Positive b-hCG Rate

时间窗: 6 months

Postoperative 6. months positive b-hCG rates will be compared with control group.

次要结局

未报告次要终点

研究者

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

GÜRKAN UNCU,PROF. MD

Prof. Dr.

Uludag University

研究点 (1)

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