PFRET: The Predictive Value of Progesterone
Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05876234
Collaborator
(none)
3,000
1
32.2
93.1
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
- Ongoing pregnancy rate [11 to 13 weeks after ovulation]
Fetal heart beat at ultrasound
Secondary Outcome Measures
- 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