Early Luteal Phase Progesterone Kinetics After hCG-Induced Ovulation in Modified Natural Cycle

Not Applicable

Not yet recruiting

• Conditions: Luteal Phase Insufficiency
• Interventions: Drug: hCG

• Registration Number: NCT07028710
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

This pilot study evaluates how progesterone levels change after hCG-triggered ovulation in modified natural cycles. Forty women preparing for frozen embryo transfer will have blood tests over 6 days to monitor hormone levels. The goal is to understand whether hCG affects the timing of the luteal phase and embryo implantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Study First Posted: 2025-06-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Study Start: 2025-09-15
• Primary Completion: 2028-06-15
• Study Completion: 2030-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• At least 1 follicle of 17 mm or more
• Endometrium of 6 mm or more
• Plasma luteinizing hormone (LH) less than 2 times basal level (measured at the beginning of the cycle between D1 and D4) and progesteronemia less than 1.5 ng/mL
• For whom ovulation induction with recombinant hCG (Ovitrelle) is then proposed (standard care).

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Exclusion Criteria

• Patient whose venous capital contraindicates repeated blood sampling over a short period of time over a short period.
• Patient treated with exogenous natural progesterone (vaginal or injectable) which may interfere or synthetic progesterone, which may interfere with endogenous progesterone secretion.
• Patient who has not given written consent to participate in the study.
• Patient not fluent in French.
• Patient under guardianship, curators or without social security coverage.
• Patient participating in another study with an ongoing exclusion period or other interventional research with no ongoing exclusion period involves the use of a drug or procedure capable of altering progesterone levels .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	hCG	-

Primary Outcome Measures

Name	Time	Method
Serum Progesterone Level on Day 3 After hCG Trigger	3 Days After hCG Injection