Guangdong Provincial Endometriosis Clinical Research Cohort

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Endometriosis-Related Pain Recurrence [Срок оценки: From enrollment through 24 months]

Вторичные конечные точки (2)

• Endometriosis-Related Cyst Recurrence [Срок оценки: From enrollment through 24 months]
• Live Birth During Follow-Up [Срок оценки: From enrollment through 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Guangdong Women and Children Hospital — Гуанчжоу

Публикации

• Sharma S, Bathwal S, Agarwal N, Chattopadhyay R, Saha I, Chakravarty B. Does presence of adenomyosis affect reproductive outcome in IVF cycles? A retrospective analysis of 973 patients. Reprod Biomed Online. 2019 Jan;38(1):13-21. doi: 10.1016/j.rbmo.2018.09.014. Epub 2018 Oct 26. PMID 30446308
• Marcellin L, Leconte M, Gaujoux S, Santulli P, Borghese B, Chapron C, Dousset B. Associated ileocaecal location is a marker for greater severity of low rectal endometriosis. BJOG. 2019 Dec;126(13):1600-1608. doi: 10.1111/1471-0528.15901. Epub 2019 Sep 4. PMID 31407476
• Rowlands IJ, Abbott JA, Montgomery GW, Hockey R, Rogers P, Mishra GD. Prevalence and incidence of endometriosis in Australian women: a data linkage cohort study. BJOG. 2021 Mar;128(4):657-665. doi: 10.1111/1471-0528.16447. Epub 2020 Sep 1. PMID 32757329

Идентификаторы

NCT: NCT07749053 · GDWCH-ENDO-PROS-01 · 20250070 · 20250134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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