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| Name | Class |
|---|---|
| Centre National de la Recherche Scientifique, France | OTHER |
| Fondation pour la Recherche sur l'Endométriose | UNKNOWN |
| Fondation pour la Recherche Médicale | OTHER |
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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 :
For the ENDO + group only:
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:
Both samples will be taken at t0 (before watching the video) and t1 (20 minutes after watching the video).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENDO + | Patients with endometriosis diagnosed by Magnetic Resonance Imaging (MRI) or laparoscopy |
| |
| ENDO - | Patients without endometriosis diagnosed by laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| At diagnosis or at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Basal total testosterone | The basal total testosterone (Ttotal(t0)) level is measured in blood | t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video |
| Basal bio-available testosterone |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (for the ENDO+ group only) | 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 |
Inclusion Criteria:
Specific criteria (ENDO+ group) :
Specific criteria (ENDO- group) :
• Patient without endometriosis confirmed by laparoscopy
Exclusion Criteria:
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Women with or without endometriosis
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra ALVERGNE, PhD | Centre National de la Recherche Scientifique, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D000098845 | Developmental Origins of Health and Disease |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Université Montpellier |
| OTHER |
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Serums and saliva extracts before and after wathching the empathy-inducing video
|
| Saliva samples for oxytocin measurements | Other | Several measurements of the oxytocin concentration will be performed on 2 ml saliva samples:
|
|
The basal bio-available testosterone (Tbio-available(t0)) level is measured in blood
| 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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)) | 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)) | 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 | 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%). | 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." | t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video |
| 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) | 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). | t0 : Between the second and the fifth day of the menstrual cycle, before wathching empathy-inducing video |
| D000091662 | Genital Diseases |
| D011297 | Prenatal Exposure Delayed Effects |
| D049188 | Prenatal Injuries |
| D011248 | Pregnancy Complications |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |