Infertility FemaleKARU-FERTILNCT07231510
Chlordecone Exposure and Female Fertility
An observational study of Infertility Female, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility Female
- How many people
- 634 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 26 Jan 2024to 26 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Women consulting for couple infertility in Guadeloupe.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guadeloupe1 site, 1 recruiting
- Recruiting
Chu de La Guadeloupe
Pointe-à-Pitre, 97159
Léah MICHINEAU, +590690483336, leah.michineau@inserm.fr
melanie.petapermal@chu-guadeloupe.fr
About this study
Official title: 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.
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.
- Conditions
- Infertility Female
- Keywords
- polycystic ovarian syndrome, endometriosis, female infertility,, ovarian reserve, environmental exposures, chlordecone, kepone
- Medical subject headings
- Infertility, Female, Polycystic Ovary Syndrome, Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: between days 2 and 4 of the spontaneous menstrual cycle
AMH levels and antral follicle count according to the levels of other POPs
AMH levels and antral follicle count
Measured: baseline
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
Measured: baseline
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.
Measured: changes from baseline to 2 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start26 Jan 2024
- Primary completion26 Jan 2026 (estimated)
- Study completion26 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 634 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Guadeloupe, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Ronan Garlantezec, MD PhD, Study director, CHU de Rennes - Université de Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231510
- Sponsor's protocol ID
- PAP_RIPH2_2023/08
- Other IDs
- 2023-A01755-40
- Acronym
- KARU-FERTIL
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KARU-FERTIL: Chlordecone Exposure and Female Fertility
- ClinicalTrials.gov ID
- NCT07231510
- Acronym / sponsor ID
- KARU-FERTIL / PAP_RIPH2_2023/08
- Conditions
- Infertility Female
- Keywords
- polycystic ovarian syndrome, endometriosis, female infertility,, ovarian reserve, environmental exposures, chlordecone, kepone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- Institut Pasteur de Guadeloupe, Rennes University Hospital
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 26 Jan 2026 (estimated)
- Study completion
- 26 Jan 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women consulting for couple infertility in Guadeloupe.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronan Garlantezec, MD PhD study director
CHU de Rennes - Université de Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Female, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie petapermal (+590590934667, melanie.petapermal@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.