Uterine FibroidNCT05840042
Epidemiology and Risk Factors of Uterine Fibroids in China
An observational study of Uterine Fibroid, run by Wenwen Wang at 1 site in China.
Trial summary
Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroid
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study population is women aged more than 18yrs with or without uterine fibroids from five regions of China. The study time period will conduct from May 1, 2023 - November 30, 2025 to allow for 6 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of one years follow-up.
Who may be able to join
- Current place of residence≥ 6 months;
- No serious mental illness or mental abnormality;
- Those who agree to participate in this survey and cooperate in completing the questionnaire.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
MINLI ZHANG, MASTER contact
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Shixuan Wang, PhD, 86-27-83663078, shixuanwang@tjh.tjmu.edu.cn
About this study
Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.
- Conditions
- Uterine Fibroid
- Medical subject headings
- Leiomyoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of uterine fibroids in China
Prevalence of uterine fibroids in China
Measured: Baseline
Secondary outcomes (2)
Incidence of uterine fibroids in China
Incidence of uterine fibroids in China
Measured: Two follow-ups over a three-year period
Risk factors of development of uterine fibroids in China
Associated risk factors for recurrence, infertility and malignancy of uterine fibroids in China
Measured: Two follow-ups over a three-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenwen Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, The Fourth Hospital of Shijiazhuang
- Responsible party
- Sponsor-investigator, Wenwen Wang, Tongji Hospital
- Investigators
- SHIXUAN WANG, DOCTOR, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840042
- Sponsor's protocol ID
- V2.0
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan W, Yuan S, Zhou D, Zhang M, Yang S, Wang W, Wang S. Status and treatment of patients with uterine fibroids in hospitals in central China: a retrospective study from 2018 to 2021. BMJ Open. 2024 Jan 17;14(1):e081736. doi: 10.1136/bmjopen-2023-081736.
PubMed 38233053
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Risk Factors of Uterine Fibroids in China
- ClinicalTrials.gov ID
- NCT05840042
- Acronym / sponsor ID
- V2.0
- Conditions
- Uterine Fibroid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Wenwen WangUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, Tongji Hospital, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, The Fourth Hospital of Shijiazhuang
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study population is women aged more than 18yrs with or without uterine fibroids from five regions of China. The study time period will conduct from May 1, 2023 - November 30, 2025 to allow for 6 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of one years follow-up.
Key inclusion criteria (3 listed)
- Current place of residence≥ 6 months;
- No serious mental illness or mental abnormality;
- Those who agree to participate in this survey and cooperate in completing the questionnaire.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of uterine fibroids in China
Time frame: Baseline
Prevalence of uterine fibroids in China
2 secondary outcomes
Incidence of uterine fibroids in China
Time frame: Two follow-ups over a three-year period
Risk factors of development of uterine fibroids in China
Time frame: Two follow-ups over a three-year period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 38233053Yan W, Yuan S, Zhou D, Zhang M, Yang S, Wang W, Wang S. Status and treatment of patients with uterine fibroids in hospitals in central China: a retrospective study from 2018 to 2021. BMJ Open. 2024 Jan 17;14(1):e081736. doi: 10.1136/bmjopen-2023-081736.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MINLI ZHANG, MASTER contact
SHIXUAN WANG, DOCTOR principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid, run by Wenwen Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WENWEN WANG, DOCTOR (15927167698, petrawang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of uterine fibroids in China (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.