EndometriosisENDOHaDNCT05951452
The Developmental Origins of Endometriosis
An observational study of Endometriosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Blood samples for testosterone and SHBG measurements and Saliva samples for oxytocin measurements
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 17 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- Adult
Study population: Women with or without endometriosis
Who may be able to join
- 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
Show all 9Show fewer
- Painful symptoms
- Specific criteria (ENDO- group) :
- Patient without endometriosis confirmed by laparoscopy
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- Blood samples for testosterone and SHBG measurements, Saliva samples for oxytocin measurements
- Keywords
- Endometriosis, Testosterone, Oxytocin, DOHaD
- Medical subject headings
- Endometriosis, Developmental Origins of Health and Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for testosterone and SHBG measurementsOther
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
Saliva samples for oxytocin measurementsOther
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
| Study group | Role | What they receive |
|---|---|---|
| ENDO + | Patients with endometriosis diagnosed by Magnetic Resonance Imaging (MRI) or laparoscopy Receives: Other: Blood samples for testosterone and SHBG measurements; Other: Saliva samples for oxytocin measurements | |
| ENDO - | Patients without endometriosis diagnosed by laparoscopy Receives: Other: Blood samples for testosterone and SHBG measurements; Other: Saliva samples for oxytocin measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At diagnosis or at inclusion
Secondary outcomes (17)
Basal total testosterone
The basal total testosterone (Ttotal(t0)) level is measured in blood
Measured: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
Basal bio-available testosterone
The basal bio-available testosterone (Tbio-available(t0)) level is measured in blood
Measured: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
Basal sex hormone-binding globulin
Basal sex hormone-binding globulin (SHBG(t0)) level is mesured in blood
Measured: t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video
Basal Free Androgen Index
Basal Free Androgen Index (FAI(t0)) = (Ttotal(t0)/SHBG(t0))*100
Measured: t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video
Total testosterone after empathy induction
The total testosterone level after empathy induction (Ttotal(t1)) is measured in blood
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Bio-available testosterone after empathy induction
The bio-available testosterone level after empathy induction (Tbio-available(t1)) is measured in blood
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Sex hormone-binding globulin after empathy induction
Sex hormone-binding globulin after empathy induction (SHBG(t1)) is mesured in blood
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Free Androgen Index after empathy induction
Free Androgen Index after empathy induction (FAI(t1)) = (Ttotal(t1)/SHBG(t1))*100
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in total testosterone levels before and after an empathy-inducing video
The level of variation in total testosterone before (t0) and after watching empathy-inducing video (t1) is assessed according to: Ttotal(t1)-Ttotal(t0)
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in bio-available testosterone levels before and after an empathy-inducing video
The level of variation in bio-available testosterone before (t0) and after watching empathy-inducing video (t1) is assessed according to: Tbio-available(t1)-Tbio-available(t0)
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in Sex hormone-binding globulin levels before and after an empathy-inducing video
The level of variation in Sex hormone-binding globulin before (t0) and after watching empathy-inducing video (t1) is assessed according to: SHBG(t1)-SHBG(t0)
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
% of variation in Free Androgen Index before and after an empathy-inducing video
% of variation in Free Androgen Index before (t0) and after watching empathy-inducing video (t1) is assessed according to: [[FAI(t1)-FAI(t0)]/FAI(t0)] × 100
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Basal oxytocin (OT) level
The basal OT level is measured by the dosage in the saliva of :
Total OT (OTtotal(t0))
Measured: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
Oxytocin (OT) level after empathy induction
The basal OT level is measured by the dosage in the saliva of :
Total OT (OTtotal(t1))
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in oxytocin (OT) level before and after an empathy-inducing video
Variation in OT level before (t0) and after watching an empathy-inducing video (t1) is assessed in the saliva according to:
- OTtotal(t1)-OTtotal(t0)
-% of variation of OT = [[OT(t1)-OT(t0)]/OT(t0)] × 100
Measured: t1 : Between the second and the fifth day of the menstrual cycle, after wathching empathy-inducing video
Area under the Receiving Operator Characteristic (ROC) curve for AGD
The ROC curve is a graphical representation that illustrates the performance of a binary classification model. It plots the true positive rate (sensitivity) against the false positive rate (1 - specificity) at various classification thresholds. In other words, the model's sensitivity corresponds to the model's ability to detect patients (ENDO+) while the model's specificity corresponds to the model's ability to detect a non-patient (ENDO-). The ROC curve helps assess the model's ability to correctly identify true positives while minimizing false positives.
The area under the ROC curve (AUC) can be interpreted as the probability that, among two randomly chosen subjects, a patient and a non-patient, the value of the marker is higher for the patient than for the non-sick. An AUC of 0.5 (50%) indicates that the marker is non-informative. An increase in AUC indicates an improvement in discriminatory abilities, with a maximum of 1.0 (100%).
Measured: At diagnosis (ENDO+) or at enrollment (ENDO-)
Pelvic pain intensity
Pelvic pain will be assessed using a Visual Analogue Scale (VAS). The visual analog scale (VAS) is a validated, unidimensional subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start8 Jan 2024
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Fondation pour la Recherche sur l'Endométriose, Fondation pour la Recherche Médicale, Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Alexandra ALVERGNE, PhD, Study chair, Centre National de la Recherche Scientifique, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951452
- Sponsor's protocol ID
- RECHMPL23_0057
- Acronym
- ENDOHaD
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Developmental Origins of Endometriosis
- ClinicalTrials.gov ID
- NCT05951452
- Acronym / sponsor ID
- ENDOHaD / RECHMPL23_0057
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Testosterone, Oxytocin, DOHaD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Fondation pour la Recherche sur l'Endométriose, Fondation pour la Recherche Médicale, Université Montpellier
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDO + | – | Other: Blood samples for testosterone and SHBG measurements, Other: Saliva samples for oxytocin measurementsPatients with endometriosis diagnosed by Magnetic Resonance Imaging (MRI) or laparoscopy |
| ENDO - | – | Other: Blood samples for testosterone and SHBG measurements, Other: Saliva samples for oxytocin measurementsPatients without endometriosis diagnosed by laparoscopy |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with or without endometriosis
Key inclusion criteria (9 listed)
- 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)
- Stage III or IV endometriosis confirmed by laparoscopy or by laparotomy or MRI
Key exclusion criteria (20 listed)
- Ovarian stimulation planned within 3 months
- Adenomyosis
- Use of a copper coil
- Polycystic ovary syndrome
- Pudendal neuralgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for testosterone and SHBG measurementsSeveral 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 | ENDO +, ENDO - |
| Saliva samples for oxytocin measurementsSeveral 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 | Other | ENDO +, ENDO - |
Primary outcome
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.
17 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
Basal bio-available testosterone
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
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 Free Androgen Index
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video
Total testosterone after empathy induction
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Bio-available testosterone after empathy induction
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Sex hormone-binding globulin after empathy induction
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Free Androgen Index after empathy induction
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in total testosterone levels before and after an empathy-inducing video
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in bio-available testosterone levels before and after an empathy-inducing video
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in Sex hormone-binding globulin levels before and after an empathy-inducing video
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
% of variation in Free Androgen Index before and after an empathy-inducing video
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Basal oxytocin (OT) level
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
Oxytocin (OT) level after empathy induction
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
Variation in oxytocin (OT) level before and after an empathy-inducing video
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching empathy-inducing video
Area under the Receiving Operator Characteristic (ROC) curve for AGD
Time frame: At diagnosis (ENDO+) or at enrollment (ENDO-)
Pelvic pain intensity
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra ALVERGNE, PhD study chair
Centre National de la Recherche Scientifique, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the anogenital distance (AGD) (time frame: At diagnosis or at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.