NCT07028710

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
50mo left

Started Jan 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Jun 2030

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2030

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

June 11, 2025

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum Progesterone Level on Day 3 After hCG Trigger

    3 Days After hCG Injection

Study Arms (1)

1

EXPERIMENTAL
Drug: hCG

Interventions

hCGDRUG

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

1

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mizrachi Y, Horowitz E, Ganer Herman H, Farhi J, Raziel A, Weissman A. Should women receive luteal support following natural cycle frozen embryo transfer? A systematic review and meta-analysis. Hum Reprod Update. 2021 Jun 22;27(4):643-650. doi: 10.1093/humupd/dmab011.

    PMID: 33829269BACKGROUND
  • Lee VC, Li RH, Chai J, Yeung TW, Yeung WS, Ho PC, Ng EH. Effect of preovulatory progesterone elevation and duration of progesterone elevation on the pregnancy rate of frozen-thawed embryo transfer in natural cycles. Fertil Steril. 2014 May;101(5):1288-93. doi: 10.1016/j.fertnstert.2014.01.040. Epub 2014 Mar 3.

    PMID: 24602752BACKGROUND

Related Links

Study Officials

  • Noémie RANISAVLJEVIC, Investigator Coordinator

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra

CONTACT

Anne CADENE, Project manager

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2030

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share