NCT05951452·Not applicable·OBSERVATIONAL

The Developmental Origins of Endometriosis

Oxytocin Other Completed

Status

Completed

Phase

Not applicable

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

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

From registration to results.

First posted
Jul 19, 2023
Study start
Jan 8, 2024
Primary completion
Jun 17, 2026
Study completion
Jun 17, 2026
Results posted
Not reported
Registry updated
Jun 18, 2026

Outcomes

What the study measures.

Primary outcomes

Measure of the anogenital distance (AGD)

Time frame · At diagnosis or at inclusion

AGD is measured at enrollment for patients already diagnosed by Magnetic resonance imaging (MRI), and it is measured during the laparoscopy once the diagnosis has been confirmed. AGD is measured by 2 different operators with a millimetric precision ruler according 2 validated methods : * measure of the distance from the clitoral surface to the anus (AGD-AC), and * measure of the distance from the posterior fourchette to the anus (AGD-AF). The method is described here: https://www.jove.com/v/57912/ Each operator will measure the AGD-AC and the AGD-AF 3 times. For each type of AGD, the final value will correspond to the mean of the 6 values.

Secondary outcomes

Basal total testosterone

Time frame · t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video

The basal total testosterone (Ttotal(t0)) level is measured in blood

Basal bio-available testosterone

Time frame · t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video

The basal bio-available testosterone (Tbio-available(t0)) level is measured in blood

Basal sex hormone-binding globulin

Time frame · t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video

Basal sex hormone-binding globulin (SHBG(t0)) level is mesured in blood

Basal Free Androgen Index

Time frame · t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video

Basal Free Androgen Index (FAI(t0)) = (Ttotal(t0)/SHBG(t0))\*100

Total testosterone after empathy induction