Viewing Study NCT05951452



Ignite Creation Date: 2024-05-06 @ 7:17 PM
Last Modification Date: 2024-10-26 @ 3:03 PM
Study NCT ID: NCT05951452
Status: RECRUITING
Last Update Posted: 2024-05-03
First Post: 2023-06-29

Brief Title: The Developmental Origins of Endometriosis
Sponsor: University Hospital Montpellier
Organization: University Hospital Montpellier

Study Overview

Official Title: The Developmental Origins of Endometriosis
Status: RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ENDOHaD
Brief Summary: Introduction

Endometriosis is a common pathology affecting one in 10 women characterized by the ectopic development of endometrium which can cause pain andor 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None