Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET): a Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Maternal: Relaxin-2 plasma concentrations.
研究概览
简要总结
In pregnancies achieved through programmed frozen embryo transfer cycle (PC-FET) and modified natural frozen embryo transfer (mNC-FET), to determine whether there are differences in endothelial and placental function, maternal cardiovascular function, fetal growth and fetal cardiovascular and cerebral programming and to assess whether there is an association between these differences and the plasma concentrations of the main secretion products of the Corpus Luteum (CL) with vasoactive and angiogenic action.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients 18- 37 years old (both included) at the time of oocyte retrieval and less than 41 years of age at the time of embryo transfer.
- •Regular menstrual cycles between 24 and 35 days.
- •Availability of cryopreserved blastocysts from own gametes
- •Indication for single embryo transfer.
- •Patients who will be included in the LUTI study are candidates for either of the two procedures under study, and will have no contraindications for either procedure.
排除标准
- •Recurrent pregnancy loss (3 or more).
- •Recurrent implantation failure in previous IVF treatments (3 or more unsuccessful embryo transfers). .
- •Diagnosis of polycystic ovarian syndrome, diabetes mellitus, chronic arterial hypertension, maternal heart disease and autoimmune diseases (Systemic Lupus Erythematosus (SLE) or Antiphospholipid syndrome (APS)).
- •Active treatment with aspirin, heparin or other anticoagulant therapy, antihypertensives or other drugs used to treat circulation or coagulation disorders .
- •Indication for PGT (Preimplantation Genetic Testing).
- •Multiple pregnancy.
研究组 & 干预措施
PC-FET (endometrial preparation with absence of CL)
Pregnancies with absence of corpus luteum
干预措施: Estradiol + Progesterone (Drug)
NC-FET (natural cycle FET, endometrial preparation with presence of CL)
Pregnancies with presence of corpus luteum
干预措施: Ovitrelle ( Hcg 250 mcg) (Drug)
结局指标
主要结局
Maternal: Relaxin-2 plasma concentrations.
时间窗: Up to 10 month
Fetal: Mitral annular plane systolic excursion (MAPSE) assessed by echocardiography.
时间窗: Up to 10 month
次要结局
- Angiogenic/vasoactive function of corpus luteum and placenta(Up to 10 month)
- plasma concentrations of VCAM-1 and endoglin.(Up to 10 month)
- Maternal endothelial function(Up to 10 month)
- Maternal echocardiography: cardiac output (L/min)(Up to 10 month)
- Fetal programming(Up to 10 month)
- Fetal growth(At 20, 28, 32, and 36 week of gestation.)
- Neonatal data(At Delivery)
- Placental study(At Delivery)
- Preconceptional parameters(Visit 0 (Baseline))
- Maternal Cardivascular Function(Up to 10 month)
- left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5).(Up to 10 month)