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PFRET: The Predictive Value of Progesterone

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05876234
Collaborator
(none)
3,000
Enrollment
1
Location
32.2
Anticipated Duration (Months)
93.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. We assess whether the addition of SC P4 rescues cycles with serum P4 <5 ng/ml and we study the impact of not supplementing cycles with serum P4 >5 ng/ml by comparing them with serum P4 cycles above the conventionally proposed cut-off of 10 ng/ml.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Predictive Value of the Progesterone Level on the Day of Embryo Transfer in Cryo Cycles
    Actual Study Start Date :
    Apr 25, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Ongoing pregnancy rate [11 to 13 weeks after ovulation]

      Fetal heart beat at ultrasound

    Secondary Outcome Measures

    1. Clinical pregnancy rate [6 to 8 weeks after ovulation]

      Positive hCG and ultrasound visualisation of the gestational sac

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 47 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    • Embryo transfer between March 1st 2021 and March 31st 2023

    • Determination of progesterone on the day of embryo transfer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ghent University Hospital - Department of Reproductive Medicine Ghent Belgium 9000

    Sponsors and Collaborators

    • University Hospital, Ghent

    Investigators

    • Principal Investigator: Dominic Stoop, MD, University Hospital, Ghent

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT05876234
    Other Study ID Numbers:
    • ONZ-2023-0223
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 25, 2023