Guangdong Provincial Endometriosis Clinical Research Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis

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.

• Study Type: Observational
• Enrollment (Estimated): 716

Contacts and Locations

• Study Contact: Name: Li Li, MD; Phone Number: +85213631446859; Email: lili-1406@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 511442
      • Recruiting
      • Guangdong Women and Children Hospital
      • Contact: Li Li, MD; Phone Number: +85213631446859; Email: lili-1406@163.com
      • Contact: Li Li, MD; Email: lili-1406@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 45 years receiving evaluation or clinical care for endometriosis at Guangdong Women and Children Hospital will be prospectively recruited into the endometriosis cohort. Age- and body mass index-matched healthy women with regular menstrual cycles will be recruited as a comparison cohort. Participants will be followed for 24 months according to the study protocol.

Description

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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Endometriosis Cohort; Women aged 18 to 45 years with endometriosis diagnosed based on clinical findings, imaging, and/or laparoscopy will be prospectively enrolled and followed for 24 months. Baseline disease characteristics, routine clinical treatments, pain outcomes, cyst recurrence, and reproductive outcomes will be recorded.
Healthy Control Cohort; Age- and body mass index-matched healthy women aged 18 to 45 years with regular menstrual cycles of 28 to 30 days will be prospectively enrolled as a comparison cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis-Related Pain Recurrence	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	From enrollment through 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis-Related Cyst Recurrence	The number and percentage of participants in the endometriosis cohort with a recurrent endometriosis-related cyst documented during follow-up.	From enrollment through 24 months
Live Birth During Follow-Up	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.	From enrollment through 24 months

Collaborators and Investigators

• Sponsor: Li Li

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: August 1, 2026
• First Submitted That Met QC Criteria: August 1, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Infertility; Live Birth; Pregnancy Outcome; Pelvic Pain; Prospective Cohort; Ovarian Endometrioma; Disease Recurrence
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Infertility; Endometriosis; Pelvic Pain
• Other Study ID Numbers: GDWCH-ENDO-PROS-01; 20250070 (Other Identifier: Guangdong Women and Children Hospital Ethics Committee); 20250134 (Other Identifier: Guangdong Women and Children Hospital Clinical Research Management Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No