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NCT05876234 Clinical Trial

The Predictive Value of Progesterone

Subfertility Clinical Trial

— PFRET  

Official title:
The Predictive Value of the Progesterone Level on the Day of Embryo Transfer in Cryo Cycles

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05876234
Other study ID # ONZ-2023-0223
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 25, 2023
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 47 Years
Eligibility - Embryo transfer between March 1st 2021 and March 31st 2023 - Determination of progesterone on the day of embryo transfer

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Ghent University Hospital - Department of Reproductive Medicine Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ongoing pregnancy rate Fetal heart beat at ultrasound 11 to 13 weeks after last menstruation
Secondary Clinical pregnancy rate Ultrasound visualisation of the gestational sac 6 to 8 weeks after last menstruation
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