The Developmental Origins of Endometriosis (NCT05951452) | Clinical Trial Compass
CompletedNot Applicable
The Developmental Origins of Endometriosis
France40 participantsStarted 2024-01-08
Plain-language 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).
Who can participate
Age range
20 Years – 38 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 unde…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at something called anogenital distance as a way to understand the origins of endometriosis — can you explain what anogenital distance is and why researchers think it might be linked to how endometriosis develops?
2Since this trial has already been completed, has any data or findings been published yet, and if so, what might those results mean for understanding my own diagnosis or risk factors?
3This study focuses on the developmental origins of endometriosis, meaning it's looking at biological factors that may have been present from early in life — does that kind of research have any practical implications for how my endometriosis would be treated or managed right now?
4Since this appears to be an observational study rather than a treatment trial, are there any active treatment-focused clinical trials for endometriosis that might be worth considering alongside or instead of standard care options?
5Could the type of research being done in this study — looking at physical markers and developmental biology — eventually lead to earlier diagnosis of endometriosis, and is that something that's relevant to my situation or to other family members who might be at risk?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.