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Plasma Relaxin Measurement Based on Endometrial Preparation for Embryo Transfer (TEC-RELAX)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Begins enrollment this month

Conditions

Infertility
Embryos Transfert

Treatments

Biological: Relaxine dosage

Study type

Observational

Funder types

Other

Identifiers

NCT07477340
69HCL26_0142

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

60 participants in 3 patient groups

Fresh ambryo transfert
Treatment:
Biological: Relaxine dosage
Frozen embryo transfert with Follicle stimulating hormone
Treatment:
Biological: Relaxine dosage
Frozen embryo transfert with hormonal substitutive treatment cycle
Treatment:
Biological: Relaxine dosage

Trial contacts and locations

1

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Central trial contact

FRAISON Eloise, Dr

Data sourced from clinicaltrials.gov

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