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NCT Number: NCT07028710

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

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.

Recruiting

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Arnaud de Villeneuve

Montpellier, 34000, France

Location status: Recruiting

Location contact

Noémie RANISAVLJEVIC

CONTACT

[email protected]

04 67 33 64 81 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

HCG

Drug

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

Primary outcomes

  1. Serum Progesterone Level on Day 3 After hCG Trigger

    Time frame: 3 Days After hCG Injection

Study contacts

Contact information is provided by the study sponsor or research team.

Anne CADENE, Project manager

CONTACT

[email protected]

04.67.33.08.14

Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra

CONTACT

[email protected]

04 67 33 64 81

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: CineP4

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 19, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.