Early Luteal Phase Progesterone Kinetics After hCG-Induced Ovulation in Modified Natural Cycle (CineP4)

June 17, 2026 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: hCG
Subcutaneous injection of 250 µg of recombinant hCG (Ovitrelle®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Progesterone Level on Day 3 After hCG Trigger
Time Frame: 3 Days After hCG Injection
3 Days After hCG Injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Noémie RANISAVLJEVIC, Investigator Coordinator, CHU de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2030

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

June 11, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RECHMPL24_0200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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