Relaxin Measurement in Different Endometrial Preparation Approaches for Frozen Embryo Transfer

NCT ID: NCT06526520

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Frozen Embryo Transfer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Natural cycle

Monitoring of a natural cycle

No interventions assigned to this group

natural proliferative phase cycle

Monitoring of a natural proliferative phase cycle

Exposure to progesterone or HRT medication

Intervention Type DRUG

to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol

Hormonal replacement cycle

Monitoring of a hormonal replacement cycle

Exposure to progesterone or HRT medication

Intervention Type DRUG

to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol

Interventions

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Exposure to progesterone or HRT medication

to add either progesterone only in the NPP protocol or E2 and progesterone in a HRT protocol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Lawrenz, PhD

Role: PRINCIPAL_INVESTIGATOR

ART Fertility Clinic

Locations

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ART Fertiltiy Clinic

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Barbara Lawrenz, M.D. PhD

Role: CONTACT

800 337845489

Jonalyn Edades, MBA

Role: CONTACT

800 337845489

Facility Contacts

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Barbara Lawrenz

Role: primary

00971526500757

Jonalyn Edades, MBA

Role: backup

Other Identifiers

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2406-ABU-007-BL

Identifier Type: -

Identifier Source: org_study_id

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