ClinicalTrials.gg
RecruitingNCT07749053Updated Aug 6, 2026

Guangdong Provincial Endometriosis Clinical Research Cohort

An observational study in Endometriosis, sponsored by Li Li. Recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Li Li · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
716
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 47 studies in Endometriosis with a site in China — 16 open to participants now, 17 under way, 2 of them phase 3. Endometriosis · China.

Planned enrollment
7th of 19
716 · median 402
Started
2026
with 5 others
Observational
19 of 47
9 open now
Primary completion
2029-07
later than 14 of 16 live
Registered
45th of 47
by date

Among the 47 studies in Endometriosis with a site in China, this one is the 7th largest by planned enrollment of the 19 observational ones, is one of 6 that started in 2026, is one of 19 observational ones, reaches primary completion later than 14 of the 16 other live ones, and was the 45th registered.

By phase

47 studies; the count open now beside each. This study's row is marked.

Observationalthis study19 · 9 open
No phase9 · 3 open
Phase 36 · 2 open
Phase 15 · 1 open
Phase 24 · 1 open
Phase 43 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2008; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 161 across the 28 interventional studies, 402 across the 19 observational. Of the 16 that completed or were terminated, 3 (19%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 47 studies in Endometriosis with a site in China, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Endometriosis

Keywords

  • Prospective Cohort
  • Ovarian Endometrioma
  • Pelvic Pain
  • Disease Recurrence
  • Pregnancy Outcome
  • Live Birth
  • Infertility
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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.

Eligibility criteria

Inclusion Criteria:

  • Inclusion Criteria:

Female participants aged 18 to 45 years. Able and willing to provide written . 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 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:

-

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
716 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: From enrollment through 24 months

Secondary outcomes

  1. Endometriosis-Related Cyst Recurrence

    The number and percentage of participants in the endometriosis cohort with a recurrent endometriosis-related cyst documented during follow-up.

    Time frame: From enrollment through 24 months

  2. 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.

    Time frame: From enrollment through 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 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. PubMed 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. PubMed 32757329 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jul 2029, 41 months after the start.

Of 155 non-industry observational studies under Endometriosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 41 months is above that.

Counting every sponsor, half of 182 studies reached it within 30 months; a quarter within 14 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2026
First posted
Aug 6, 2026
StartActual
Feb 2, 2026
Primary completionEst.
Jul 2029
CompletionEst.
Jul 2029
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07749053
Lead sponsor
Li Li
Responsible party
Li Li (Chief Physician, Guangdong Women and Children Hospital) — Sponsor-investigator
First posted
Aug 6, 2026
Start date
Feb 2, 2026
Primary completion
Jul 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
Aug 6, 2026

Study contacts

Li Li, MD
Contact
lili-1406@163.com
+85213631446859

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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