NCT05876234

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

April 25, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
2.6 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

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

2.7 years

First QC Date

May 8, 2023

Last Update Submit

June 3, 2024

Conditions

Subfertility

Keywords

progesteroneembryo transfer

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Fetal heart beat at ultrasound

    11 to 13 weeks after last menstruation

Secondary Outcomes (1)

  • Clinical pregnancy rate

    6 to 8 weeks after last menstruation

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Treated at Ghent University Hospital

* Embryo transfer between March 1st 2021 and March 31st 2023 * Determination of progesterone on the day of embryo transfer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital - Department of Reproductive Medicine

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Dominic Stoop, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 25, 2023

Study Start

April 25, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

BE(1)