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Recruiting Observational

Metabolism, Circadian Rhythms and Ovarian Function

NCT05007834 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-02-24
Last updated
2025-12-26

Condition(s) studied

Chemotherapy-Induced Amenorrhea

Study summary

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

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
35 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Concentration of IL-6 levels at the end of chemotherapy — 1 year
    Study the association between the IL-6 blood levels (in pg/ml) at the end of chemotherapy and the menstrual period return state ( before or after 6 months)

Trial sites (1)

FacilityCityRegionStatus
Hop Jeanne de Flandre Chu Lille Lille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05007834 on ClinicalTrials.gov ↗ ← All trials in France