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临床试验/NCT07477340
NCT07477340尚未招募不适用

Plasma Relaxin Measurement Based on Endometrial Preparation for Embryo Transfer

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Relaxin Level

研究概览

简要总结

Pregnancies achieved through assisted reproductive technology (ART) are associated with more obstetric complications than natural pregnancies.

In pregnancies achieved through in vitro fertilization, different obstetric outcomes are observed depending on the type of embryo transfer performed and the type of endometrial preparation. Studies comparing obstetric complications according to the type of transfer performed (fresh or frozen embryo transfer) suggest an increased risk of preeclampsia, fetal macrosomia, and postpartum hemorrhage in pregnancies achieved through frozen embryo transfer.

Depending on the endometrial preparation methods used prior to frozen embryo transfer, different obstetric risks are observed. Comparisons mainly focus on stimulated cycles versus natural cycles and spontaneous pregnancies. Pregnancies achieved through frozen embryo transfer in a stimulated cycle are thought to be at greater risk of preeclampsia, fetal macrosomia, and postpartum hemorrhage than natural cycles and spontaneous pregnancies. One of the first markers of this vascular adaptation is the cranio-caudal length (CCL).

Indeed, the cranio-caudal length of embryos in the first trimester is a good reflection of embryonic growth and therefore of vascular adaptation in the first trimester of pregnancy. Differences in growth between embryos from fresh transfers, frozen transfers, and spontaneous pregnancies are visible early on, as early as the first trimester.

The hypotheses put forward to explain these differences include the secretion of relaxin by the corpus luteum, which is present in the natural cycle but not in the substituted cycle. This hormone plays a role in cardiovascular and renal adaptation to pregnancy in the first trimester. Low levels of relaxin would therefore be associated with poorer cardiorenal adaptation in the first trimester and thus with greater vascular risks in late pregnancy.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primiparous women
  • Intra-couple ART
  • Of childbearing age undergoing assisted reproductive technology (18 to 44 years and 11 months)
  • Who underwent a fresh or frozen embryo transfer during the inclusion period resulting in a progressing monofetal pregnancy (ultrasound showing an embryo with cardiac activity).
  • Able to understand the ins and outs of the study
  • Having indicated their willingness to participate in the study

排除标准

  • Uterine pathologies (adenomyosis, fibroids)
  • Multiple pregnancies
  • Spontaneous pregnancy
  • Pregnancy through gamete donation
  • Refusal to undergo obstetric ultrasounds
  • Subject participating in interventional research involving an exclusion period still ongoing at the time of pre-inclusion

研究组 & 干预措施

Fresh ambryo transfert

干预措施: Relaxine dosage (Biological)

Frozen embryo transfert with Follicle stimulating hormone

干预措施: Relaxine dosage (Biological)

Frozen embryo transfert with hormonal substitutive treatment cycle

干预措施: Relaxine dosage (Biological)

结局指标

主要结局

Relaxin Level

时间窗: Up to 19 weeks

Determine whether there is a difference in plasmatic relaxin levels in ng/ml depending on the type of transfer-fresh transfer versus TEC THS versus TEC FSH.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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