Chlordecone Exposure and Female Fertility (KARU-FERTIL)

November 14, 2025 updated by: Centre Hospitalier Universitaire de la Guadeloupe

KARU-FERTIL: Chlordecone Exposure and Female Fertility

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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. Chlordecone is an endocrine-disrupting chemical with well-defined estrogenic and progestagenic properties in vivo and in vitro. To date, no study has been published concerning the link between chlordecone exposure and female fertility. Nevertheless, mammalian studies in females have consistently reported that chlordecone exposure impairs ovulation and leads to a reduced ovarian reserve. In addition, there are questions about the impact of other environmental exposures, including by non-targeted approaches, and also of the vaginal and endometrial microbiome on female fertility.

Study Type

Observational

Enrollment (Estimated)

634

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women consulting for couple infertility in Guadeloupe.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of AMH according to terciles of chlordecone levels.
Time Frame: AMH levels will be measured during the assessment conducted for assisted reproductive technology (ART) and will date from less than one year before inclusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of antral follicles according to terciles of chlordecone levels.
Time Frame: between days 2 and 4 of the spontaneous menstrual cycle
Transvaginal ultrasound for antral follicle count will be performed between days 2 and 4 of the spontaneous menstrual cycle, the number of antral follicles corresponds to the total number of antral follicles in both ovaries, with a diameter between 2 and 10 mm.
between days 2 and 4 of the spontaneous menstrual cycle
AMH levels and antral follicle count according to the levels of other POPs
Time Frame: baseline
AMH levels and antral follicle count
baseline
relationship between exposure to chlordecone and other POPs and the risk of the main causes of female infertility
Time Frame: baseline
main causes of female infertility : Endometriosis ; Polycystic ovary syndrome (PCOS) ; Decreased ovarian reserve
baseline
Chlordecone levels according to the outcomes of IVF/ICSI management:
Time Frame: changes from baseline to 2 years after

relationship between occupational exposure to solvents and others factors described :

  • Endometrial thickness,
  • Peak estraiol,
  • Number of oocytes collected,
  • Number of mature oocytes collected,
  • Number of zygotes,
  • Embryo quality,
  • Blastocyst number,
  • Number of frozen embryos,
  • Biological pregnancy,
  • Clinical pregnancy,
  • Live birth.
changes from baseline to 2 years after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Collaborators

Rennes University Hospital
Institut Pasteur de Guadeloupe

Investigators

  • Study Director: Ronan Garlantezec, MD PhD, CHU de Rennes - Université de Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

January 26, 2026

Study Completion (Estimated)

January 26, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAP_RIPH2_2023/08
  • 2023-A01755-40 (Registry Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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