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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

Luteal Phase Insufficiency

Treatments

Drug: hCG

Study type

Interventional

Funder types

Other

Identifiers

NCT07028710
RECHMPL24_0200

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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).

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 .

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

1
Experimental group
Treatment:
Drug: hCG

Trial contacts and locations

0

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Central trial contact

Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra; Anne CADENE, Project manager

Data sourced from clinicaltrials.gov

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