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RecruitingNCT07231510KARU-FERTILUpdated Nov 17, 2025

Chlordecone Exposure and Female Fertility

An observational study in Infertility Female, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
634
Ages
18 Years to 39 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility Female

Keywords

  • polycystic ovarian syndrome
  • endometriosis
  • female infertility,
  • ovarian reserve
  • environmental exposures
  • chlordecone
  • kepone
03

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women consulting for couple infertility in Guadeloupe.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
634 participants (estimated)
Patient registry
No
05

What researchers measure

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.

    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

Secondary outcomes

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

    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.

    Time frame: between days 2 and 4 of the spontaneous menstrual cycle

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

    AMH levels and antral follicle count

    Time frame: baseline

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

    main causes of female infertility : Endometriosis ; Polycystic ovary syndrome (PCOS) ; Decreased ovarian reserve

    Time frame: baseline

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

    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.

    Time frame: changes from baseline to 2 years after

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07231510
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Collaborators
Institut Pasteur de Guadeloupe, Rennes University Hospital
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Jan 26, 2024
Primary completion
Jan 26, 2026 (estimated)
Completion
Jan 26, 2028 (estimated)
Last update
Nov 17, 2025

Study contacts

Mélanie petapermal
Contact
melanie.petapermal@chu-guadeloupe.fr
+590590934667
Valérie Hamony Soter
Contact
valerie.soter@chu-guadeloupe.fr
+590590934677
Ronan Garlantezec, MD PhD
study director · CHU de Rennes - Université de Rennes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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