The Developmental Origins of Endometriosis

Status Recruiting

Clinical Trial Summary

Introduction: Endometriosis is a common pathology affecting one in 10 women, characterized by the ectopic development of endometrium, which can cause pain and/or infertility. This pathology is primarily determined by hereditary factors, but it is also susceptible to environmental influences, such as the age of the onset of menstruation or exposure to chemical substances that modify the endocrine system. Recent studies have highlighted that endometriosis is more common in women with relatively short ano-genital distances (AGD), and that sensitivity to pain is closely linked to adult levels of testosterone (T) or oxytocin (OT). Aim: The main objective is to compare the anogenital distance (AGD) between two groups of women: one with stage III or IV endometriosis (ENDO +) and another group without endometriosis confirmed by laparoscopy (ENDO -). The secondary objectives are to compare various factors between the 2 groups : - Basal testosterone levels in blood. - Variations in blood testosterone levels before and after a video stimulating empathy. - Basal oxytocin levels in saliva. - Variations in oxytocin levels in saliva before and after an empathy-stimulating video. - Pelvic pain, between D2 and D5 after the start of the menstrual cycle. For the ENDO + group only: - Evaluate patients' quality of life, between D2 and D5 after the start of the menstrual cycle. - Correlate pain experienced over the last 4 weeks with hormonal markers (AGD, T, OT). Methods: Participants in the ENDO+ group will fill in a questionnaire assessing the impact of pain experienced over the past 4 weeks on their quality of life. D0 is defined as the day when participants experience a menstrual bleed before 10 am. All participants will return for project-specific hospital appointment between D2 and D5 after the start of their menstrual cycle to measure T, Sex Hormone-Binding Globulin (SHBG) and OT. During this consultation, the following samples will be taken: - 10mL blood sample - 2mL saliva sample Both samples will be taken at t0 (before watching the video) and t1 (20 minutes after watching the video).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Endometriosis

Clinical Trial Details

NCT number	NCT05951452
Study type	Observational
Source	University Hospital, Montpellier
Contact	Alexandra ALVERGNE, PhD
Phone	+334.67.14.46.15
Email	alexandra.alvergne@umontpellier.fr
Status	Recruiting
Phase
Start date	January 8, 2024
Completion date	December 1, 2026

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Developmental Origins of Endometriosis — ENDOHaD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms