NCT07231510

Brief Summary

Chlordecone is an organochlorine pesticide used in the French West Indies (FWI) from 1972 to 1993 to control the banana root borer. Due to its very long persistence the population continues to be exposed to this chemical through their food consumptions. Although, chlordecone have been associated in animal study impairment of ovarian reserve, to date, no study has been published concerning the link between chlordecone exposure and female fertility. The main objective of this project is to study the association between chlordecone exposure and anti-mullerian hormone (AMH) in women consulting for couple infertility in Guadeloupe.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
634

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress57%
Jan 2024Jan 2028

Study Start

First participant enrolled

January 26, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2028

Expected
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

polycystic ovarian syndromeendometriosisfemale infertility,ovarian reserveenvironmental exposureschlordeconekepone

Outcome Measures

Primary Outcomes (1)

  • Levels of AMH according to terciles of chlordecone levels.

    The purpose is to study the association between chlordecone exposure and AMH levels in women consulting for couple infertility in Guadeloupe.

    AMH levels will be measured during the assessment conducted for assisted reproductive technology (ART) and will date from less than one year before inclusion

Secondary Outcomes (4)

  • Number of antral follicles according to terciles of chlordecone levels.

    between days 2 and 4 of the spontaneous menstrual cycle

  • AMH levels and antral follicle count according to the levels of other POPs

    baseline

  • relationship between exposure to chlordecone and other POPs and the risk of the main causes of female infertility

    baseline

  • Chlordecone levels according to the outcomes of IVF/ICSI management:

    changes from baseline to 2 years after

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women consulting for couple infertility in Guadeloupe.

You may qualify if:

  • Women aged from 18 to 39 years
  • Consulting for couple infertility at the Centre Caribéen de Médecine de la Reproduction (CCMR, Caribbean Center for Reproductive Medicine) of the University Hospital of Guadeloupe
  • Free, informed and written consent

You may not qualify if:

  • Women aged from 18 to 39 years
  • Consulting for couple infertility at the Centre Caribéen de Médecine de la Reproduction (CCMR, Caribbean Center for Reproductive Medicine) of the University Hospital of Guadeloupe
  • Free, informed and written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de La Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

RECRUITING

MeSH Terms

Conditions

Infertility, FemalePolycystic Ovary SyndromeEndometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ronan Garlantezec, MD PhD

    CHU de Rennes - Université de Rennes

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 17, 2025

Study Start

January 26, 2024

Primary Completion

January 26, 2026

Study Completion (Estimated)

January 26, 2028

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations