NCT05951452

The Developmental Origins of Endometriosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: —

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).

Conditions

• Endometriosis

Interventions

Type	Name	Description
OTHER	Blood samples for testosterone and SHBG measurements	Several measurements of the testosterone concentration will be performed on serum from 10 mL of blood collected at: * t0 corresponding to the start of the hospital appointment and before watching the video * t1 which corresponds to 20 minutes after watching a 2 minutes empathy-inducing video
OTHER	Saliva samples for oxytocin measurements	Several measurements of the oxytocin concentration will be performed on 2 ml saliva samples: * t0 corresponding to 20 minutes after the start of the hospital appointment and before watching the video * t1 which corresponds to 20 minutes after watching a 2 minutes empathy-inducing video

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-08-08
• Completion: 2026-10-08
• First posted: 2023-07-19
• Last updated: 2026-02-25

Locations

1 site across 1 country: France