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

NCT ID: NCT07028710

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2030-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Luteal Phase Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

hCG

Intervention Type DRUG

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

Interventions

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hCG

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

Intervention Type DRUG

Eligibility Criteria

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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 .
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noémie RANISAVLJEVIC, Investigator Coordinator

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier

Central Contacts

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Noémie RANISAVLJEVIC, Senior Lecturer - Hospital Pra

Role: CONTACT

04 67 33 64 81

Anne CADENE, Project manager

Role: CONTACT

04.67.33.08.14

References

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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.

Reference Type BACKGROUND
PMID: 33829269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24602752 (View on PubMed)

Related Links

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Other Identifiers

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RECHMPL24_0200

Identifier Type: -

Identifier Source: org_study_id

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