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Clinical Trials/NCT06526520
NCT06526520RecruitingNot Applicable

Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer

ART Fertility Clinics LLC2 sites in 1 country5 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
5
Locations
2
Primary Endpoint
Relaxin measurement

Study Overview

Brief Summary

To investigate the levels of Relaxin in different types of endometrial preparation for a frozen embryo transfer cycle. Up to now it is unclear, whether ovulation with a functional corpus luteum (CL) will be present in a natural proliferative phase (NPP) endometrial preparation approach.

Detailed Description

The last years have seen a distinct shift from fresh (fresh ET) to frozen embryo transfer (FET) cycles. Furthermore it became obvious, that the endometrial preparation approach has a significant impact on the course of the pregnancy and that a HRT endometrial preparation approach is associated with a higher risk for bleeding and miscarriages in early pregnancy and for the development of pregnancy induced hypertension and pre-eclampsia later in pregnancy.

These conditions are attributed to the absence of a CL in the HRT approach. Lately a new endometrial preparation approach is discussed and performed, the so called natural proliferative phase protocol, in which the follicle growth is monitored and when the lining is deemed to have a sufficient thickness and the triple lining pattern, exogeneous progesterone is started to induce secretory transformation before spontaneous ovulation. Despite some studies showing, that exogeneous progesterone administration might induce ovulation, it is not clear whether there will be a CL, producing Relaxin, in the NPP approach.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • regular menstrual cycles

Exclusion Criteria

  • abnormal findings of the ovaries (e.g endometriosis)
  • Intake of any hormones within 3 months of study start
  • desire to become pregnant

Arms & Interventions

natural proliferative phase cycle

Monitoring of a natural proliferative phase cycle

Intervention: Exposure to progesterone or HRT medication (Drug)

Hormonal replacement cycle

Monitoring of a hormonal replacement cycle

Intervention: Exposure to progesterone or HRT medication (Drug)

Outcomes

Primary Outcomes

Relaxin measurement

Time Frame: 4 to 6 months

Measurement of Relaxin in the different types of frozen embryo transfer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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