Detection of Kisspeptins and miRNAs in Patients With Non-viable Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 4
- 主要终点
- Level of Kisspeptin 54
研究概览
简要总结
Ectopic pregnancy (EP) is a pathology that affects 3%-16% of pregnancies in humans, being the main cause of morbidity and maternal mortality in the first trimester of pregnancy worldwide. The relevance of this problem has led to a demand on the scientific community, to obtain specific and early biomarkers in the determination of EP. In this context, the investigator's group has previously confirmed that both kisspeptin 54 and miR-324-3p are specific, selective and precise biomarkers to identify those patients suffering an EP. However, the utility of a diagnostic test using both biomarkers and other related ones in a population with other types of non-viable pregnancies should still be analysed.
详细描述
This is a pilot study in which we intend to determine the moment in which biomarkers begin to be detected in non-viable pregnancies, in order to subsequently be able to develop specific studies focused on that moment. The following visits will be required:
SCREENING VISIT: To be performed before β-hCG test. After recruitment and signing informed consent, patients will be assigned with a three-letter code identifying the clinic and three numbers indicating the order in which the patient is recruited by each clinic.
β-hCG VISIT: To be performed the day of the β-hCG test (week 4):
- Peripheral blood samples will be collected for Progesterone (P4), Kisspeptin 54 and miR-324-3p analysis.
In case of negative result, patient will be out of the study. In case of positive result, β-hCG test > 10 UI/L, patient will continue with the following visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who will perform SET.
- •Patients using own oocytes.
排除标准
- •Complicated uterine cavity.
研究组 & 干预措施
Patients with viable pregnancy
Patients with β-hCG test > 10 UI/L whose pregnancy is confirmed between gestational weeks 6 and 8.
干预措施: Blood samples collection for analysis (Diagnostic Test)
Patients with biochemical pregnancy
Patients with β-hCG test > 10 UI/L and without sac observed.
干预措施: Blood samples collection for analysis (Diagnostic Test)
Non-pregnant patients
Patients with β-hCG test < 10 UI/L.
干预措施: Blood samples collection for analysis (Diagnostic Test)
Patients with ectopic pregnancy
Patients with β-hCG test > 10 UI/L whose sac is implantated outside the uterine cavity.
干预措施: Blood samples collection for analysis (Diagnostic Test)
Patients with clinical miscarriage
Patients with β-hCG test > 10 UI/L whose sac is implanted inside the uterine cavity, but non-viable pregnancy is confirmed before gestational week 8.
干预措施: Blood samples collection for analysis (Diagnostic Test)
结局指标
主要结局
Level of Kisspeptin 54
时间窗: Mar 2019 - Oct 2021
Level in peripheral blood of Kisspeptin 54
Level of miR-324-3p
时间窗: Mar 2019 - Oct 2021
Level in peripheral blood of miR-324-3p
次要结局
- Oral glucose tolerance test (OGTT)(Mar 2019 - Oct 2021)
- Level of progesterone(Mar 2019 - Oct 2021)
- Level of hormone β-hCG(Mar 2019 - Oct 2021)
- KIR typing(Mar 2019 - Oct 2021)
- HLA-C typing(Mar 2019 - Oct 2021)
- Level of miRNAs related with insulin resistance, miR-424-5p and miR-15b(Mar 2019 - Oct 2021)