Evolution of Endometriosis Lesions and Quality of Life of Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months
研究概览
简要总结
The goal of this prospective cohort study is to determine the factors that influence the progression of endometriosis and the quality of life of patients.
The main questions it aims to answer are:
- Is endometriosis a progressive disease?
- Is the progression of lesions visualized by ultrasound dependent on the medical treatment received?
- Does the clinical progression of patients correlate with the progression of lesions visualized on transvaginal ultrasound?
- Is ultrasound follow-up necessary for patients?
- Could clinical follow-up alone be safe for selected patients?
Researchers will follow up a prospective cohort of 100 patients diagnosed with deep infiltrating endometriosis (DIE) +/- endometriomas during 2 years, collecting data regarding their ultrasound exam and their symptoms and quality of life at stablished controls at recruitment, 6 months, 12 months and 24 months.
详细描述
This prospective observational cohort study aims to characterize the clinical and ultrasonographic progression of endometriosis and to identify the factors associated with disease evolution, ovarian reserve, symptom burden, and patient-reported quality of life. The protocol is designed to integrate longitudinal clinical assessments, structured transvaginal ultrasound evaluations, hormonal profiling, and digital monitoring through the validated mobile application "Endometric".
The study will follow a cohort of adult women with confirmed endometriosis for two years, using standardized evaluation intervals (baseline, 6 months, 1 year, and 2 years) to capture meaningful changes in lesion morphology, symptoms, and functional outcomes.
Ultrasound assessments will be performed according to the IDEA consensus (Guerriero S, et al. Systematic approach to sonographic evaluation of the pelvis in women with suspected endometriosis, including terms, definitions and measurements: a consensus opinion from the International Deep Endometriosis Analysis (IDEA) group. Ultrasound Obstet Gynecol. 2016 Sep;48(3):318-32. doi: 10.1002/uog.15955) and lesions will be classified using the Enzian system (Keckstein J, et al. The #Enzian classification: A comprehensive non-invasive and surgical description system for endometriosis. Acta Obstet Gynecol Scand. 2021 Jul;100(7):1165-75. doi: 10.1111/aogs.14099), enabling precise measurement of endometriomas, deep infiltrating lesions, associated adhesions, and adnexal involvement.
Ovarian reserve will be estimated using antral follicle count and antimüllerian hormone (AMH) levels, analyzed in a single specialized laboratory to minimize inter-assay variability. Clinical progression will be assessed through standardized symptom scales and the Endometriosis Health Profile Questionnaire (EHP-30). Participants will be managed with expectant, medical, or combined approaches according to routine clinical practice; treatments will not be randomized, but exposure will be precisely documented to evaluate its relationship with disease evolution.
The study functions as a patient registry with predefined longitudinal data collection and structured quality-assurance procedures. Data will be stored in a dedicated Clinapsis database with controlled access and pseudonymization through unique patient codes. A detailed data dictionary will define each variable, its source, coding strategy (including standardized terminology for medications and symptoms), and reference ranges for biological parameters. Automated data-entry checks will detect inconsistencies, missing fields, and out-of-range values at the point of entry. Additional validation procedures will include periodic cross-checks between electronic case-report forms and source data (ultrasound measurements, laboratory results, medical records). Source data verification will be conducted by authorized investigators to ensure accuracy and completeness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a confirmed diagnosis of endometriosis, based on ultrasound criteria. Diagnosis must be confirmed by transvaginal ultrasound with evidence of visible and measurable endometriotic lesions.
- •Patients over 18 years of age. This criterion ensures that participants can provide informed consent and are of reproductive age, when the effects of endometriosis and its treatments are relevant to the study.
- •A transvaginal ultrasound performed prior to enrollment showing endometriotic lesions (either endometriomas or deep lesions) with sufficient dimensions and characteristics for evaluation and follow-up.
- •Patients who do not have an indication for scheduled surgery within the next two years. This ensures that the effects of treatment and the progression of the disease can be evaluated throughout the study follow-up period.
- •Signed informed consent from the patient, indicating that she has understood the purpose of the study, the procedures involved, and the potential risks.
排除标准
- •Patients with an indication for scheduled surgical treatment within the next two years. This includes patients requiring surgery for the removal of endometriotic lesions or to address related complications.
- •Patients who are unwilling to undergo follow-up transvaginal ultrasound at scheduled visits (6 months, 1 year, 2 years). Ultrasound is essential for assessing disease progression and the impact of treatment.
- •Patients who are unwilling to participate in the study after receiving all the information and providing their informed consent. Voluntary participation is crucial for the ethics of the study.
- •Patients with intellectual disabilities or conditions that impair their understanding of the study terms and procedures, which could affect their ability to provide valid informed consent.
- •Patients who are pregnant or breastfeeding at the time of enrollment. These conditions can influence the course of endometriosis and the response to treatment, and could complicate disease monitoring.
- •Patients with serious concurrent illnesses or medical conditions that may interfere with the assessment of endometriosis, its progression, or the impact of treatment (e.g., severe chronic inflammatory diseases or cancer).
- •Patients receiving concurrent treatments not permitted by the study protocol (e.g., experimental treatments for endometriosis or related conditions) that may interfere with the interpretation of the results.
结局指标
主要结局
Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months
时间窗: From enrollment to the end of follow-up at 24 months
* Ultrasound data used: * Number of lesions (endometriomas and DIE lesions). * Size (assessed in mm; 3 diameters) and characteristics of endometriomas and DIE lesions (described according to IDEA criteria). * Presence or absence of hydronephrosis, adhesions, and hydrosalpinx. * Ultrasound classification according to Enzian Clssification. Outcome variable: PROGRESSION, STABILITY or REGRESSION. This result will be defined as follows: * PROGRESSION: Increase of \> 5mm in the maximum lesion measurement and/or appearance of new lesions and/or increase of 1 point in any item of the Enzian classification. * STABILITY: increase/decrease \<5mm in the maximum lesion measurement and same number of identified lesions and no changes in the score of any item of the Enzian classification. * REGRESSION: decrease \> 5mm in the maximum lesion measurement and/or disappearence of any of the previously described lesions and/or decrease of 1 point in any item of the Enzian classification.
Evolution of clinical presentation at recruitment, 6, 12 and 24 months
时间窗: From enrollment to the end of follow-up at 24 months
* Symptoms: numeric pain rating scale (zero is equivalent to no pain and 10 indicates the worst possible pain) * Dysmenorrhea * Chronic pelvic pain * Dyschezia * Dyspareunia * Dysuria * Subjective evolution according to patient impressions: Likert scale ("significant improvement" / "moderate improvement" / "stability" / "mild worsening" / "significant worsening")
次要结局
- Evolution of Ovarian Reserve at recruitment, 6, 12 and 24 months(From enrollment to the end of follow-up at 24 months)
- Evolution of Quality of Life (QoL) at recruitment, 6, 12 and 24 monts(From enrollment to the end of follow-up at 24 months)
研究者
Aina Delgado Morell
Co-Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau