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临床试验/NCT03690830
NCT03690830Unknown不适用

Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1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
40
试验地点
2
主要终点
Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites)

研究概览

简要总结

It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already composed as part of a pre-existing research project and 1 control group including patients undergoing ART for male factor infertility.

The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.

详细描述

The investigators have designed a unicentric, case-control, retro- and prospective study to compare the endometrial metabolomics profile in three groups of patients. The two case groups (RIF and IRPL) are already composed and the endometrial and blood samples already taken as part of a pre-existing research project. The current protocol concerns the control group that includes patients undergoing ART for male factor infertility.

The study will include three groups. The first group is composed of patients with a history of RIF following IVF-ET. RIF is defined as failure to obtain a clinical pregnancy (fetal cardiac activity at 6-7 weeks gestational age (GA)) following at least 3 different transfers of at least 4 good quality embryos (fresh or frozen).

The second group comprises patients with a history of IRPL, defined as three or more consecutive pregnancy losses that occurred before 14 weeks gestational age. Early pregnancy losses diagnosed before ultrasonographic confirmation will be included.

The third group will include patients undergoing ART for male factor infertility.

The study protocol will be presented and explained to all eligible patients in the control group during the routine consultation before treatment. Patients who agree to participate will contact the department to program the inclusion visit with one of the attending physicians in the department, during which the blood and endometrial samples will be taken. The inclusion visit will take place at the department of reproductive medicine of Angers University Hospital around day 21 of the menstrual cycle (in the middle of the implantation window, which occurs between day 19 and 23 of the cycle, day 1 being the first menstruation day).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18 (included) and 40 years (excluded).
  • Patients who agreed to participate and signed the consent form
  • Patients undergoing ART for male factor infertility: male partner with severe oligoasthenospermia or azoospermia.
  • Patients without any prior history of infertility or risk factors for infertility other than the male factor.
  • Patients with a normal basic infertility workup prior to ART (Day 3 serum FSH, LH, Estradiol and AMH; Antral follicle count; hysterosonography or hysterosalpingography)

排除标准

  • Non-French speaking patients.
  • Major patients that are wards of the nation.
  • Patients deprived of their liberty on criminal charges or for civil reasons.
  • Patients under psychiatric care.
  • Patients under legal protection.
  • Patients unable to sign consent forms.
  • Patients not covered by social security (which covers all treatments administered).
  • Patients currently participating in other interventional research projects.

研究组 & 干预措施

Case group RIF

Experimental

blood samples, analyzing endometrial cells

干预措施: metabolomics analysis (Other)

Case group IRPL

Experimental

blood samples, analyzing endometrial cells

干预措施: metabolomics analysis (Other)

Control group

Active Comparator

blood samples, analyzing endometrial cells

干预措施: metabolomics analysis (Other)

结局指标

主要结局

Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites)

时间窗: 1 day

To compare the metabolomics profile of the endometrium in patients with RIF or IRPL following IVF-ET to patients undergoing Assisted Reproductive Technologies (ART) for male factor infertility to see if there is any significant difference, qualitative or quantitative or both in the metabolites.

次要结局

  • Analyze the blood sample with standard biological examination and the endometrial sample with mass spectrometry using the Biocrates kit(1 day)
  • Analyze the endometrial samples with mass spectrometry using the Biocrates kit(1 day)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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