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

Evolution of Luteal Progesteronemia in a Modified Natural Cycle (Ovulation Triggered by hCG): Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07028710
Acronym
CineP4
Enrollment
40
Registered
2025-06-19
Start date
2026-01-12
Completion date
2030-06-15
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Luteal Phase Insufficiency

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.

Interventions

DRUGhCG

Subcutaneous injection of 250 µg of recombinant hCG (Ovitrelle®)

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* At least 1 follicle of 14 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).

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 .

Design outcomes

Primary

MeasureTime frame
Serum Progesterone Level on Day 3 After hCG Trigger3 Days After hCG Injection

Countries

France

Contacts

CONTACTNoémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra
n-ranisavljevic@chu-montpellier.fr04 67 33 64 81
CONTACTAnne CADENE, Project manager
a-cadene@chu-montpellier.fr04.67.33.08.14
PRINCIPAL_INVESTIGATORNoémie RANISAVLJEVIC, Investigator Coordinator

CHU de Montpellier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026