The Predictive Value of Progesterone

Active, not recruiting

• Conditions: Subfertility

• Registration Number: NCT05876234
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	11 to 13 weeks after last menstruation	Fetal heart beat at ultrasound

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6 to 8 weeks after last menstruation	Ultrasound visualisation of the gestational sac

Trial Locations

Locations (1)

Ghent University Hospital - Department of Reproductive Medicine; 🇧🇪 Ghent, Belgium