Modelization of Early Endometrial-trophoblast Molecular Interaction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Determine transcriptionnal and proteic signatures of endometrial-trophoblast
研究概览
简要总结
Despite significant advances in assisted reproductive technology, only 25% of in vitro fertilization (IVF) embryo transfers result in pregnancy, largely due to implantation failure. Preeclampsia complicates 2 to 5% of pregnancies, causes 76,000 maternal deaths worldwide each year, and is one of the leading causes of extreme prematurity (20% of premature births occurring before 32 weeks of gestation). The MEETMI project aims to characterize, in the laboratory, the early endometrium-trophoblast molecular interactions that determine the initial stages of human implantation and placentation. As part of routine care, patients will undergo a diagnostic hysteroscopy during which a endometrial biopsy may be performed. If the patient consents to participate in the study, an additional extended endometrial biopsy will be collected for research purposes.
详细描述
Despite significant advances in assisted reproductive technology, only 25% of in vitro fertilization (IVF) embryo transfers result in pregnancy, largely due to implantation failure.
Preeclampsia complicates 2 to 5% of pregnancies, causes 76,000 maternal deaths worldwide each year, and is one of the leading causes of extreme prematurity (20% of premature births occurring before 32 weeks of gestation). There is no curative treatment, and only delivery of the baby and placenta can cure the patient. During preeclampsia, early placental abnormalities occur in the first trimester of pregnancy, even though the initial stages of human embryo implantation (apposition, adhesion, invasion) and early placentation remain poorly understood.
The primary objective of the MEETMI project is to characterize, in the laboratory, the early endometrium-trophoblast molecular interactions that determine the initial stages of human implantation and placentation.
It is essential to collect human endometrial cells (epithelial and stromal cells) from endometrial biopsies performed as part of routine care in patients who have been previously informed and have given their consent to the research.
For the placental part, following models available in the Lecarpentier's laboratory at the Institut Cochin will be used: human trophoblast stem cells (hTSCs), placental organoids derived from first-trimester placenta .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Medical indication for a diagnostic hysteroscopy between the ages of 18 and 50
- •Comprehensive information provided prior to the hysteroscopy
- •Informed consent signed by the patient
排除标准
- •Current pregnancy
- •Age < 18 or > 50
- •Patient refusal
- •Woman under court-ordered protection
- •Not enrolled in the general social security system
- •Patient who is HIV- or HCV-positive, regardless of viral load
- •Patient whose medical history requires medication that may interfere with trophoblast biology (immunomodulators in cases of autoimmune diseases, anti-rejection drugs in transplant patients)
- •Known genetic disorder in the patient
- •Unable to understand and sign the consent form
研究组 & 干预措施
Hysteroscopy arm
Patients will undergo a diagnostic hysteroscopy during which a endometrial biopsy may be performed. An additional extended endometrial biopsy will be collected for research purposes.
干预措施: Diagnostic hysteroscopy with endometrial biopsy (Procedure)
结局指标
主要结局
Determine transcriptionnal and proteic signatures of endometrial-trophoblast
时间窗: Day 20
Determine transcriptionnal and proteic signatures of endometrial-trophoblast
次要结局
- Placental Penetration into the extracellular matrix(Day 20)
- Viability of the co-culture(Day 20)
- Development of syncytiotrophoblast: To vizualise syncytiotrophoblast development: hCG concentration in co-culture supernatant(Day 20)
- Development of syncytiotrophoblast: sFLT1 concentration in co-culture supernatant(Day 20)
- Development of syncytiotrophoblast: PlGF concentration in co-culture supernatant(Day 20)
- Development of syncytiotrophoblast: Fusion index(Day 20)