Chlordecone Exposure and Female Fertility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infertility Female. Basic parameters: 18 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Guadeloupe
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
KARU-FERTIL: Chlordecone Exposure and Female Fertility
Overview
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.
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Number of antral follicles according to terciles of chlordecone levels. [Time frame: 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]
- relationship between exposure to chlordecone and other POPs and the risk of the main causes of female infertility [Time frame: baseline]
- Chlordecone levels according to the outcomes of IVF/ICSI management: [Time frame: changes from baseline to 2 years after]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Guadeloupe · 1 center
- Chu de La Guadeloupe — Pointe-à-Pitre
Identifiers
NCT: NCT07231510 · PAP_RIPH2_2023/08 · 2023-A01755-40