CHU de Montpellier
Montpellier, 34295, France
NCT Number: NCT05951452
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).
Looking for future studies?
Notify Me20 year–38 year
Female
Observational
Montpellier, 34295, France
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Specific criteria (ENDO+ group) :
Specific criteria (ENDO- group) :
Exclusion criteria
Several measurements of the testosterone concentration will be performed on serum from 10 mL of blood collected at:
Several measurements of the oxytocin concentration will be performed on 2 ml saliva samples:
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 :
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
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
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
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
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
The total testosterone level after empathy induction (Ttotal(t1)) is measured in blood
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
The bio-available testosterone level after empathy induction (Tbio-available(t1)) is measured in blood
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 (SHBG(t1)) is mesured in blood
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 (FAI(t1)) = (Ttotal(t1)/SHBG(t1))*100
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching 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)
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching 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)
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching 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)
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 (t0) and after watching empathy-inducing video (t1) is assessed according to: [[FAI(t1)-FAI(t0)]/FAI(t0)] × 100
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
The basal OT level is measured by the dosage in the saliva of :
Total OT (OTtotal(t0))
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video
The basal OT level is measured by the dosage in the saliva of :
Total OT (OTtotal(t1))
Time frame: t1 : Between the second and the fifth day of the menstrual cycle, after wathching empathy-inducing video
Variation in OT level before (t0) and after watching an empathy-inducing video (t1) is assessed in the saliva according to:
-% of variation of OT = [[OT(t1)-OT(t0)]/OT(t0)] × 100
Time frame: At diagnosis (ENDO+) or at enrollment (ENDO-)
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%).
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video
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."
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video
The quality of life of patients with endometriosis is assessed with the Endometriosis Health Profile questionnaire (EHP-30©)
EHP-30 is a self-administered questionnaire validated in French to assess the effects that endometriosis can have on the quality of life of women. This questionnaire consists of 30 domains grouped into 5 areas:
Pain (11 items: n° 1 to 11), Control and helplessness (6 items: n°12 to 17), Emotional well-being (6 items: n°18 to 23), Social support (4 items: n°24 to 27), Self-image (3 items: n°28 to 30). Each item is rated on a Likert scale (Never=0, Rarely=1, Sometimes=2, Often=3, Always=4). Each domain is then represented by a score calculated on a scale from 0 (indicating the best possible state of health) to 100 (indicating the worst possible state of health): Domain score = [sum of responses to each item in the domain] / [4 (= maximum item response) × number domain items] × 100
Time frame: t0 : Between the second and the fifth day of the menstrual cycle, before wathching empathy-inducing video
The score of pain of patients with endometriosis is assessed with the French version of the Endometriosis Health Profile questionnaire (EHP-30©). The score of the first domain Pain consists of 11 items. Each item is rated on a Likert scale (Never=0, Rarely=1, Sometimes=2, Often=3, Always=4).
University Hospital, Montpellier
Other
Acronym: ENDOHaD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07241637
Endometriosis, Fatigue
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05962034
Endometriosis, Female Urogenital Diseases
University Park, Pennsylvania, United States
View Trial DetailsNCT05019612
Endometriosis, Expectations
Hamburg, Germany
View Trial DetailsNCT00073801
Chronic Pelvic Pain, Endometriosis
Bethesda, Maryland, United States
View Trial Details