NCT06526520

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 21, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

July 25, 2024

Last Update Submit

February 20, 2025

Conditions

Frozen Embryo Transfer

Keywords

frozen embryo transferhormonal replacement cyclenatural cycleRelaxin

Outcome Measures

Primary Outcomes (1)

  • Relaxin measurement

    Measurement of Relaxin in the different types of frozen embryo transfer

    4 to 6 months

Study Arms (3)

Natural cycle

Monitoring of a natural cycle

natural proliferative phase cycle

Monitoring of a natural proliferative phase cycle

Drug: Exposure to progesterone or HRT medication

Hormonal replacement cycle

Monitoring of a hormonal replacement cycle

Drug: Exposure to progesterone or HRT medication

Interventions

Exposure to progesterone or HRT medicationDRUG

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

Hormonal replacement cyclenatural proliferative phase cycle

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsregular menstrual cycles
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

\- healthy volunteers with regular cycles

You may qualify if:

  • regular menstrual cycles

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ART Fertiltiy Clinic

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests for hormonal assessment

Study Officials

  • Barbara Lawrenz, PhD

    ART Fertility Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Lawrenz, M.D. PhD

CONTACT

800 337845489barbara.lawrenz@artfertilityclinics.com

Jonalyn Edades, MBA

CONTACT

800 337845489jonalyn.edades@artfertilityclinics.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 29, 2024

Study Start

August 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

on request

Locations

AE(1)