Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut/Genital Microbiome Signatures in Women With Endometriosis

Обзор

This project PestiEndoMicro aims to provide an innovative approach, studying endometriosis under the genital and gut microbiota scope. To realize this project, the investigators are planning to dose cfDNA to assess the oxidative stress caused by endometriosis and study its epigenetics. At the same time, the investigators will take a pragmatic approach by assessing pesticide exposure in these patients and estimate the correlation between gut or genital dysbiosis and chemical agent exposure. Also, the investigators will take the initiative to use classic culture, qPCR techniques, and NGS to establish signatures in vaginal, endometrial and gut microbiota in patients with endometriosis. With these approaches, the goal is to gain more knowledge about endometriosis and optimize early diagnosis by establishing a signature in the genital and gut microbiota, but also by dosing the cfDNA. By doing so the investigators could open new opportunities to develop new therapeutic strategies for endometriosis.

Вмешательства

• Биопрепарат Circulating DNA analysis
  Circulating DNA analysis : For this study, 2 supernumerary EDTA tubes (10mL) of blood samples will be taken as part of the infectious workup.
• Биопрепарат Vaginal microbiota analysis
  Vaginal microbiota analysis : In the study, a supernumerary vaginal sample from an endocervical smear will be taken as part of the biological workup.
• Биопрепарат Endometrial microbiota analysis
  Endometrial microbiota analysis : As part of the study, an endometrial sample from a uterine rinse will be required. This flushing is a medical procedure performed outside the standard infertility or MAP management procedure and will only be carried out by a gynecologist once the patient has been included in the study and written consent has been received from the patient.
• Биопрепарат Intestinal microbiota analysis
  Intestinal microbiota analysis (secondary objective): As part of the study, a fecal sample from a patient will be required. This donation is a voluntary act on the part of the patient, outside the standard procedure for infertility treatment or MAP, and will be requested after the patient has been informed of the purpose of the procedure. Once the SHIME has been inoculated, patient donation will be no longer necessary and won't be requested from subsequent patients.
• Биопрепарат Exposure to endocrine disruptors analysis
  Exposure to endocrine disruptors analysis (secondary objective): The patient will be asked to donate a hair sample. This donation is a non-medical act performed outside the standard procedure for infertility management or MAP. In addition to hair sampling, a questionnaire on household characteristics, environment and possible exposure to endocrine disruptors will be given

Первичные конечные точки

• quantification of circulating free DNA (cfDNA) between both groups [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Variation of Vaginal microbiota signature between both groups [Срок оценки: 2 years]
• variation of Endometrial microbiota signature between both groups [Срок оценки: 2 years]
• variation of Endocrine disruptors exposure between both groups [Срок оценки: 2 years]
• variation of Intestinal microbiota signature between both groups [Срок оценки: 2 years]
• variation of DNA methylation analysis [Срок оценки: 2 years]

Критерии участия

Критерии включения

• The "case" group will include:
• All women aged 18 to 43, with confirmed endometriosis and endometriosis grade 3 or 4 as defined by the 1985 revised version of the American Society of Reproductive Medicine.
• The "control" group will include:
• All women aged between 18 and 43, whose infertility problem is proven male infertility and who do not have endometriosis identified by biological, genetic and clinical tests.
• The following criteria will apply to both groups:
• All women who have not received antibiotic treatment in the three months preceding inclusion and who are not participating in any pharmacological study.
• All women who are covered under the national social security health insurance scheme.
• All women who have signed a written informed consent form, thereby confirming their participation in the study after a period of free and informed reflection.

Критерии исключения

• All women aged 44 and over.
• Women who are overweight, obese or anorexic.
• Women taking antibiotics 3 months prior to inclusion, or participating in a drug study.
• All women under anti-GnRH treatment, pregnant or suffering from a chronic inflammatory disease such as Crohn's disease, polycystic ovary syndrome, etc.
• All women whose endometriosis has not been formally confirmed by the tests offered by the Reproductive Medicine and Biology Department, CECOS de Picardie, CHU Amiens-Picardie.
• All patients under guardianship, curators or safeguard of justice.
• All patients who have not signed the written consent confirming their participation in the study, after a period of free and informed reflection.
• Any patient who withdraws her consent for participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 1 центр

• CHRU Amiens — Salouël

Идентификаторы

NCT: NCT07471373 · PI2025_843_0212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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