Investigating the origins of endometriosis
The Developmental Origins of Endometriosis
This study looks at whether certain physical traits and hormone levels are different in women with severe endometriosis compared to those without it, to better understand what causes the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 38 Years |
| Sex | Female |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05951452 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the anogenital distance (AGD) between women with stage III or IV endometriosis and those without the condition, confirmed by laparoscopy. It will also assess blood testosterone levels and variations in oxytocin levels through saliva samples. The study focuses on understanding the hereditary and environmental factors influencing endometriosis, particularly in relation to pain sensitivity and hormonal influences. By analyzing these factors, the study seeks to provide insights into the developmental origins of endometriosis.
Who should consider this trial
Good fit: Ideal candidates include nulliparous women aged 18-35 with regular menstrual cycles, either diagnosed with stage III or IV endometriosis or confirmed to be free of the condition.
Not a fit: Patients with conditions such as polycystic ovary syndrome, chronic illnesses, or those undergoing ovarian stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of endometriosis and lead to improved diagnostic and treatment strategies for affected women.
How similar studies have performed: While the specific approach of comparing AGD in endometriosis patients is novel, related studies have shown success in understanding hormonal influences on reproductive health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Chronic exposure to cocaine, methamphetamine, morphine or ecstasy within 30 days before the inclusion visit * Chronic exposure to Tetrahydrocannabinol (THC) within 7 days prior to inclusion. * Patient on treatment(s) that vary oxytocin (e.g. atosiban), testosterone or GnRH * Pregnant or breast-feeding patient * Patients who have given birth or breastfed within 6 weeks before the inclusion visit * Patient unable to read French * Failure to obtain informed consent * Patient not affiliated with or not benefiting from a national health insurance scheme * Person under legal protection, guardianship or curatorship * Patient participating in other research involving the human person
Where this trial is running
Montpellier
- CHU de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Alexandra ALVERGNE, PhD
- Email: alexandra.alvergne@umontpellier.fr
- Phone: +334.67.14.46.15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.