EndometriosisNCT07749053
Guangdong Provincial Endometriosis Clinical Research Cohort
An observational study of Endometriosis, run by Li Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 716 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to Jul 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Women and Children Hospital
Guangzhou, Guangdong, 511442
Li Li, MD, +85213631446859, lili-1406@163.com
Li Li, MD, lili-1406@163.com
About this study
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.
Read the 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.
- Conditions
- Endometriosis
- Keywords
- Prospective Cohort, Ovarian Endometrioma, Pelvic Pain, Disease Recurrence, Pregnancy Outcome, Live Birth, Infertility
- Medical subject headings
- Endometriosis, Pelvic Pain, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment through 24 months
Secondary outcomes (2)
Endometriosis-Related Cyst Recurrence
The number and percentage of participants in the endometriosis cohort with a recurrent endometriosis-related cyst documented during follow-up.
Measured: 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.
Measured: From enrollment through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start2 Feb 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Li, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749053
- Sponsor's protocol ID
- GDWCH-ENDO-PROS-01
- Other IDs
- 20250070, 20250134
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30446308Marcellin 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.
PubMed 31407476Rowlands 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.
PubMed 32757329