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临床试验/NCT04024722
NCT04024722Unknown不适用

Improving the Results of in Vitro Fertilization in Women With Poor Ovarian Response and Early Ovarian Insufficiency

Barzilai Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月14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
40
试验地点
1
主要终点
Number of oocytes

研究概览

简要总结

Improving the results of in vitro fertilization in women with poor ovarian response and early ovarian insufficiency

详细描述

BACKGROUND: Mechanical disruption of the Hippo signaling pathway in the ovaries can increase the likelihood of pregnancy and childbirth in women with early ovarian insufficiency. The method may also "work" in women with poor ovarian reserve and poor response to routine fertility treatments.

OBJECTIVE

To examine whether mechanical stimulation of ovaries by cutting the ovarian cortex treatment can increase eggs number aspirated during In Vitro Fertilization (IVF).

METHODS: Patients eligible for the study with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of IVF success and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a pelvic ultrasound (US) and blood tests for the hormonal profile at the IVF clinic.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • •Volunteers with poor ovarian response to standard fertility treatments according to the criteria of the European Fertility Association (ESHRE).
  • •Diagnosis of early ovarian insufficiency or symptoms that predict early ovarian insufficiency (imminent) seeking to become pregnant.

排除标准

  • •Volunteers with
  • •Severe endometriosis diagnosed with laparoscopy.
  • •Previous major surgery involving ovaries.
  • •Ovarian cancer.
  • •Female reproductive malformations.
  • •Contraindications for laparoscopic surgery.

研究组 & 干预措施

Single ovary treatment

Experimental

干预措施: In Vitro Fertilization (Procedure)

Dual ovary treatment

Experimental

干预措施: In Vitro Fertilization (Procedure)

结局指标

主要结局

Number of oocytes

时间窗: up to 1 year

Number of oocytes

Embryos number

时间窗: up to 1 year

Embryos number

Fertilization rate

时间窗: up to 1 year

Fertilization rate

Pregnancies rate

时间窗: up to 1 year

Pregnancies rate

次要结局

未报告次要终点

研究者

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

Shevach Friedler, Prof

Director of IVF unit

Barzilai Medical Center

研究点 (1)

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