Guangdong Provincial Endometriosis Clinical Research Cohort

NCT07749053 | Recruiting

• 3 other identifiers: GDWCH-ENDO-PROS-012025007020250134
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Prospective Cohort; Ovarian Endometrioma; Pelvic Pain; Disease Recurrence; Pregnancy Outcome; Live Birth; Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Endometriosis-Related Cyst Recurrence

  From enrollment through 24 months

• Live Birth During Follow-Up

  From enrollment through 24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Li: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, Guangdong, 511442, China

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Li Li, MD

CONTACT

+85213631446859; lili-1406@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)