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Recruiting NCT06526520

Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer

Observational Frozen Embryo Transfer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposure to progesterone or HRT medication.
Who it may be relevant to
Registry conditions: Frozen Embryo Transfer. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Exposure to progesterone or HRT medication
    to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol

Primary outcome measures

  • Relaxin measurement [Time frame: 4 to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

United Arab Emirates · 1 center
  • ART Fertiltiy Clinic — Abu Dhabi

Identifiers

NCT: NCT06526520 · 2406-ABU-007-BL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗