Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer

Recruiting

• Conditions: Frozen Embryo Transfer
• Interventions: Drug: Exposure to progesterone or HRT medication

• Registration Number: NCT06526520
• Lead Sponsor: ART Fertility Clinics LLC

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 Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-29
• Study Start: 2024-08-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
natural proliferative phase cycle	Exposure to progesterone or HRT medication	Monitoring of a natural proliferative phase cycle
Hormonal replacement cycle	Exposure to progesterone or HRT medication	Monitoring of a hormonal replacement cycle

Primary Outcome Measures

Name	Time	Method
Relaxin measurement	4 to 6 months	Measurement of Relaxin in the different types of frozen embryo transfer

Trial Locations

Locations (1)

ART Fertiltiy Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates