Endometriosis
Conditions
Keywords
Prospective Cohort, Ovarian Endometrioma, Pelvic Pain, Disease Recurrence, Pregnancy Outcome, Live Birth, Infertility
Brief summary
Endometriosis is a chronic condition that may cause pelvic pain, ovarian cysts, infertility, and recurrent symptoms. This prospective observational cohort study will enroll women aged 18 to 45 years with endometriosis and age- and body mass index-matched healthy women. Participants will receive routine clinical care, and the study will not assign medications or procedures. Baseline clinical information will be collected, and participants will be followed for 24 months, every 3 months during the first year and every 6 months thereafter. The study will assess cyst recurrence, pain recurrence, pregnancy and live birth outcomes, and other long-term clinical outcomes. It will also evaluate associations between disease characteristics, rASRM stage, routine medical treatment, and subsequent clinical and reproductive outcomes, and will support the establishment of an endometriosis clinical research database.
Detailed description
This is a prospective observational cohort study designed to characterize the clinical course and reproductive outcomes of women with endometriosis. The study will prospectively enroll women aged 18 to 45 years with a clinical, imaging, or surgical diagnosis of endometriosis. Age- and body mass index-matched healthy women with regular menstrual cycles may also be enrolled as a control cohort. Baseline data will include demographic characteristics, reproductive history, lifestyle factors, clinical symptoms, pain scores, disease phenotype, lesion characteristics, rASRM stage, previous surgery, laboratory findings, ovarian reserve indicators, and assisted reproductive treatment information, when applicable. Treatments received as part of routine clinical care, including gonadotropin-releasing hormone agonists and progestogens, will be recorded as observational exposures. The study protocol will not assign participants to a specific medication, procedure, or assisted reproductive treatment. Participants will be followed for 24 months. Follow-up assessments will be conducted every 3 months during the first year and every 6 months thereafter, with clinically important outcome events recorded when they occur. Outcomes of interest include cyst recurrence, pain recurrence, pregnancy outcomes, live birth, and other long-term clinical complications. Associations between baseline clinical characteristics, disease severity, routine treatment patterns, and subsequent outcomes will be evaluated using appropriate descriptive and multivariable statistical methods. Time-to-event outcomes may be analyzed using Kaplan-Meier methods and Cox proportional hazards regression, with adjustment for potential confounding factors.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Inclusion Criteria: Female participants aged 18 to 45 years. Able and willing to provide written informed consent. For the endometriosis cohort: diagnosis of endometriosis based on clinical findings, imaging, and/or laparoscopy. For the endometriosis cohort: availability of complete baseline clinical data, including revised American Society for Reproductive Medicine stage and lesion type. For the healthy control cohort: healthy women matched by age and body mass index to participants in the endometriosis cohort. For the healthy control cohort: regular menstrual cycles of 28 to 30 days.
Exclusion criteria
For the endometriosis cohort: concurrent malignant tumor or severe cardiac, hepatic, or renal disease. For the endometriosis cohort: previous hysterectomy. For the endometriosis cohort: a mental disorder that prevents adherence to study follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometriosis-Related Pain Recurrence | From enrollment through 24 months | The number and percentage of participants in the endometriosis cohort who experience recurrence of endometriosis-related pain during follow-up. Pain severity will be assessed using a visual analogue scale and clinical symptom records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometriosis-Related Cyst Recurrence | From enrollment through 24 months | The number and percentage of participants in the endometriosis cohort with a recurrent endometriosis-related cyst documented during follow-up. |
| Live Birth During Follow-Up | From enrollment through 24 months | The number and percentage of participants in the endometriosis cohort with a live birth during follow-up. Live birth is defined as delivery of a live infant at 28 gestational weeks or later. |
Countries
China