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临床试验/NCT05815134
NCT05815134已完成不适用

Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年8月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
cell free DNA rate in serum in patients before they start IVF stimulation

研究概览

简要总结

Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients eligible medical assistance to procreation who are about to undergo IVF treatment
  • aged between 18 and 43 years old
  • and who have signed a consent form

排除标准

  • patients who are not eligible for medical assistance to procreation,
  • patients who are followed for other inflammatory disease,
  • patients followed for premature ovarian failure or
  • patients with a recent story of pelvic infection

研究组 & 干预措施

patients with endometriosis

Experimental

干预措施: blood sample (Biological)

others infertility causes

Active Comparator

干预措施: blood sample (Biological)

结局指标

主要结局

cell free DNA rate in serum in patients before they start IVF stimulation

时间窗: day 1

cell free DNA in serum quantified by real time PCR in patients before they start IVF stimulation

cell free DNA rate in follicular fluid the day of punction

时间窗: day 1

cell free DNA in follicular fluid the day of punction

次要结局

  • number of cells at day 3(day 3)
  • number of live birth in both groups(1 year)
  • blastulation rate at day 5 of developement(day 5)
  • number of cells at day 2(day 2)
  • number of oocytes reaching the metaphase II(1 year)
  • fragmentation rate(1 year)
  • number of clinical pregnancy in both groups(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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