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临床试验/NCT02764034
NCT02764034Available不适用

Low Level Laser Therapy to Endometrial Cells: A Novel Approach to Increase Endometrial Proliferation and Enhance Endometrial Receptivity

Cairo University1 个研究点 分布在 1 个国家开始时间: 2016年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Available
试验地点
1

研究概览

简要总结

The human endometrium is an extremely sensitive target. LLLT can enhance the proliferation rate of various cell lines, it produces higher rates of ATP, RNA, and DNA synthesis in stem cells and other cell lines. Thus, LLLT improves the proliferation of the cells without causing any cytotoxic effects.

The aim of this work is to assess the ability of low level laser therapy in enhancing endometrial proliferation and increasing endometrial receptivity.

A number of 120 human endometrial samples will be studied, and will be collected from 40 infertile women attending the infertility clinic at NRC. Each human endometrial sample will be divided into 3 plates, in order to establish 3 main groups of 40 culture plates for single laser exposure group versus 40 culture plates for multiple laser exposure group and 40 tissue culture plates for control samples, thus a total of 120 tissue culture plates will be studied, the study groups will be exposed to low level laser therapy and compared to their matched controls.. Assessment of number and size of cells after LLLT as a marker of normal proliferation and b) The expression of Integrin aVB3 "alpha v B3", MUC-1 and LIFand the development of pinopodes on the surface of epithelial cells as markers of endometrial receptivity and the detection of PTEN tumor suppressor gene as a marker of abnormal proliferation or premalignant condition will be performed to assess the effect of LLLT on the endometrial cell culture. This study might offer a new therapeutic modality which might increase endometrial thickness and enhance receptivity .

详细描述

Plan of work:

A number of 40 human endometrial samples will be collected from 40 infertile women attending the infertility clinic at the National Research Center (each sample will be divided into 3 culture plates; single exposure group, multiple exposure group and control group) and will be included in the study.

Each human endometrial sample will be divided into 3 plates, in order to establish 3 main groups of 40 culture plates for single laser exposure group versus 40 culture plates for multiple laser exposure group and 40 tissue culture plates for control samples, thus a total of 120 tissue culture plates will be studied, the study groups will be exposed to low level laser therapy and compared to their matched controls.

Timing of endometrial tissue sample:

Endometrial tissue biopsy will be performed in the early proliferative phase just after menstruation ceases (from day 5 to day8).

研究设计

研究类型
Expanded Access

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Demographic:
  • Women in child bearing period aging from 20 to 38 years.
  • Only women up to 38 years will be included, to remove advanced age as a confounding factor that could affect the study results.
  • BMI: > 20 and < 35 " BMI more 35 is excluded to remove any confounding factor related to increased BMI form the study"
  • Human endometrial sample will be obtained from infertile women with the following conditions:
  • Recurrent IUI, IVF or ICSI Failure without any clear cause.
  • Women with unexplained infertility after exclusion of all other causes of infertility and exclusion of male factor.

排除标准

  • Women with endometrial cancer or precancerous lesions.
  • Women with any malignancy of the genital tract as vulval, vaginal, cervical, ovarian and other malignancies.
  • Women undergoing dilatation and curettage due to the following conditions will be excluded:
  • Any pregnancy related pathology (eg, incomplete abortion, missed abortion, septic abortion, induced pregnancy termination, treatment and evaluation of gestational trophoblastic disease).
  • Dilatation and curettage for dysfunctional uterine bleeding; irregular bleeding or menorrhagia
  • Hormonal treatment or any medication that may affect the endometrium, including any patient received hormonal therapy in the 3 months preceding the study.
  • Before endometrial ablation for treatment of endometrial hyperplasia or perimenopausal bleeding.
  • Tissues with proved precancerous or neoplastic changes in the endometrial sample will be discarded and eliminated before initiation of the study.

研究者

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

Doaa Abdelmageed El Faham

Doctor

National Research Centre, Egypt

研究点 (1)

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