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Metabolism, Circadian Rhythms and Ovarian Function

NCT ID: NCT05007834

Last Updated: 2025-12-26

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

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-24

Study Completion Date

2026-06-30

Brief Summary

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Chemotherapy for cancer, due to its gonadotoxicity, can lead to impaired female fertility, resulting in the occurrence of transient or prolonged chemo-induced amenorrhea (CIA). According to recent data from the National Cancer Institute, 11.9% of women under the age of 40 diagnosed with cancer have been offered a fertility evaluation within five years of diagnosis. Predicting the risk and especially the duration of the CIA remains difficult. Known factors predicting a rapid return of menstruation are a young age at diagnosis, a low gonadotoxic treatment (absence of alkylating agents) and a high pre-chemotherapy blood level of AMH reflecting a large pool of growing follicles. A body mass index (BMI) ≥ 25 kg / m² could also be a positive predictor, but this remains debated.

The objective of this project is to assess the impact of metabolism and energy reserves, physical activity and the chronotype on the recovery of ovarian function in patients with breast cancer who have developed CIA

Detailed Description

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Conditions

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Chemotherapy-Induced Amenorrhea

Keywords

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Ovarian recovery Metabolism Muscular mass Adipose tissue Chronotype

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women with a chemotherapy-induced (CIA) amenorrhea who asked for post-cancer fertility follow-up at the University Hospital of Lille, France.
* Women between 25 to 35 years age at inclusion
* Chemotherapy protocol: FEC 100 (3 cycles) + docetaxel (3 cycles

Exclusion Criteria

* Women without CIA
* Women who refuse to participate in the study
* Women older than 35 years at inclusion
* Women who received another chemotherapy protocol
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal PIGNY, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pascal PIGNY, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Other Identifiers

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2021-A00461-40

Identifier Type: OTHER

Identifier Source: secondary_id

2020_16

Identifier Type: -

Identifier Source: org_study_id