The Developmental Origins of Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measure of the anogenital distance (AGD)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
ENDO -
Patients without endometriosis diagnosed by laparoscopy
干预措施: Saliva samples for oxytocin measurements (Other)
ENDO -
Patients without endometriosis diagnosed by laparoscopy
干预措施: Blood samples for testosterone and SHBG measurements (Other)
ENDO +
Patients with endometriosis diagnosed by Magnetic Resonance Imaging (MRI) or laparoscopy
干预措施: Blood samples for testosterone and SHBG measurements (Other)
ENDO +
Patients with endometriosis diagnosed by Magnetic Resonance Imaging (MRI) or laparoscopy
干预措施: Saliva samples for oxytocin measurements (Other)
结局指标
主要结局
Measure of the anogenital distance (AGD)
时间窗: 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.
次要结局
- Basal total testosterone(t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video)
- Basal bio-available testosterone(t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video)
- Basal sex hormone-binding globulin(t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video)
- Oxytocin (OT) level after empathy induction(t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video)
- Bio-available testosterone after empathy induction(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(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(t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video)
- Total testosterone after empathy induction(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(t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video)
- Area under the Receiving Operator Characteristic (ROC) curve for AGD(At diagnosis (ENDO+) or at enrollment (ENDO-))
- Pelvic pain intensity(t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video)
- Free Androgen Index after empathy induction(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(t1 : Between the second and the fifth day of the menstrual cycle, after wathching an empathy-inducing video)
- Basal oxytocin (OT) level(t0 : Between the second and the fifth day of the menstrual cycle, before wathching an empathy-inducing video)
- Basal Free Androgen Index(t0 : Between the second and the fifth day of the menstrual cycle, before watching an empathy-inducing video)
- Variation in total testosterone levels before and after an empathy-inducing video(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(t1 : Between the second and the fifth day of the menstrual cycle, after wathching empathy-inducing video)