The Developmental Origins of Endometriosis

NCT05951452 | Recruiting

• 1 other identifier: RECHMPL23_0057
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endometriosis; Testosterone; Oxytocin; DOHaD

Outcome Measures

Primary Outcomes (1)

• Measure of the anogenital distance (AGD)

  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.

  At diagnosis or at inclusion

Secondary Outcomes (17)

• Basal total testosterone

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

• Basal bio-available testosterone

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

• Basal sex hormone-binding globulin

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

• Basal Free Androgen Index

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

• Total testosterone after empathy induction

  t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video

Other Outcomes (2)

• Quality of life (for the ENDO+ group only)

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

• Score of pain (for the ENDO+ group only)

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

Study Arms (2)

ENDO +

Patients with endometriosis diagnosed by Magnetic Resonance Imaging (MRI) or laparoscopy

Other: Blood samples for testosterone and SHBG measurements; Other: Saliva samples for oxytocin measurements

ENDO -

Patients without endometriosis diagnosed by laparoscopy

Other: Blood samples for testosterone and SHBG measurements; Other: Saliva samples for oxytocin measurements

Interventions

Blood samples for testosterone and SHBG measurements OTHER

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

ENDO +; ENDO -

Saliva samples for oxytocin measurements OTHER

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

ENDO +; ENDO -

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with or without endometriosis

You may qualify if:

• Nulliparous woman
• No hormonal contraception for at least 3 months
• Regular menstrual cycles (between 26 and 32 days) or proven ovulation (positive urine ovulation test ovulation test or progesterone level \>3 ng/ml in the luteal phase)
• Normal BMI (≥ 18,5 and \< 30 kg/m²)
• Specific criteria (ENDO+ group) :
• Stage III or IV endometriosis confirmed by laparoscopy or by laparotomy or MRI
• Painful symptoms
• Specific criteria (ENDO- group) :
• Patient without endometriosis confirmed by laparoscopy

You may not qualify if:

• Ovarian stimulation planned within 3 months
• Adenomyosis
• Use of a copper coil
• Polycystic ovary syndrome
• Pudendal neuralgia
• Episiotomy or lesion of the posterior perineum that may modify AGD
• Diabetes or thyroid disease
• Chronic liver failure, chronic renal failure, cardiac pathology, autoimmune disease
• Autism
• Diagnosis and/or treatment for psychiatric illness
• Patient on treatment(s) that vary oxytocin (e.g. atosiban), testosterone or GnRH
• Pregnant or breast-feeding patient
• Patient unable to read French
• Failure to obtain informed consent
• Patient not affiliated with or not benefiting from a national health insurance scheme

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre National de la Recherche Scientifique, France: collaborator
• Fondation pour la Recherche sur l'Endométriose: collaborator
• Fondation pour la Recherche Médicale: collaborator
• Université Montpellier: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serums and saliva extracts before and after wathching the empathy-inducing video

MeSH Terms

Conditions

Endometriosis; Developmental Origins of Health and Disease

Interventions

Blood Specimen Collection; Testosterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prenatal Exposure Delayed Effects; Prenatal Injuries; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Alexandra ALVERGNE, PhD

  Centre National de la Recherche Scientifique, France

  STUDY CHAIR

Central Study Contacts

Alexandra ALVERGNE, PhD

CONTACT

+334.67.14.46.15; alexandra.alvergne@umontpellier.fr

Noémie RANISAVLJEVIC, MD

CONTACT

+334.67.33.64.81; n-ranisavjlevic@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 19, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): October 8, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)