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NCT Number: NCT07477340

Plasma Relaxin Measurement Based on Endometrial Preparation for Embryo Transfer

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Service de Médecine et de la Reproduction HFME

Bron, Rhone, 69500, France

Location contact

FRAISON Eloise, Dr

CONTACT

[email protected]

04 72 12 94 12 ext. +33

FRAISON Eloise, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxine dosage

Biological

An additionnal 5m blood sample will be taken during the current blood sample at the beginning of the pregnancy.

Primary outcomes

  1. Relaxin Level

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

FRAISON Eloise, Dr

CONTACT

[email protected]

04 72 12 94 12 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: TEC-RELAX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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