Uterine FibroidsNCT06055114
Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
An observational study of Uterine Fibroids, run by Lin Yuan.
Trial summary
The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Microscopic examination of vaginal discharge
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2023to 9 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) examined the uterine fibroid patients and healthy physical examination subjects.
Who may be able to join
- Study group inclusion criteria:
- Age 20-49 years old
- Premenopausal
- Clinical diagnosis of uterine myoma
- Cervical liquid-based cytology and human papillomavirus typing test are negative
- Healthy control group:
Show all 11Show fewer
- Age 20-49 years old
- Premenopausal
- Uterine B-ultrasonography is normal
- Cervical liquid-based cytology and human papillomavirus typing test are negative
- No vaginal infection
Who cannot join
- Used antibiotics, hormones, immunosuppressants and regulators within 1 month
- Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
- Pregnant, lactating or menstruating women
- Uterus and uterine adnexa have other lesions
- Used antibiotics, hormones, immunosuppressants and regulators within 1 month
- Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
- Pregnant, lactating or menstruating women
Trial locations and contacts
No sites are listed yet.
About this study
The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.
Read the detailed description
(1) In this study, 150 women of childbearing age who are diagnosed with uterine fibroids in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group; The differences of vaginal microenvironment and cervical local immune function are compared between 150 healthy women of childbearing age in the same period. (2) After the patients are enrolled, the general information (age, height, weight), menstrual status (age of menarche, menstrual period, cycle, bleeding pattern), clinical manifestations (abnormal uterine bleeding, infertility, abdominal pain), and previous medical history (hypertension, thyroid disease, etc.) of 150 patients with uterine fibroids will be collected. After the end of the first part of the experiment, 150 patients with uterine fibroids will be grouped according to vaginal microecological diagnosis, and the clinical characteristics of patients with uterine fibroids will be analyzed and compared.
- Conditions
- Uterine Fibroids
- Being tested
- Microscopic examination of vaginal discharge
- Keywords
- uterine fibroids, vaginal microecology, cervical local immune function, childbearing age
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic examination of vaginal dischargeDiagnostic test
Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.
| Study group | Role | What they receive |
|---|---|---|
| study group | Age 20-49 years old; Premenopausal; Clinical diagnosis of uterine myoma; Cervical liquid-based cytology and human papillomavirus typing test are negative. Receives: Diagnostic Test: Microscopic examination of vaginal discharge | |
| Healthy control group | Age 20-49 years old; Premenopausal; Uterine B-ultrasonography is normal; Cervical liquid-based cytology and human papillomavirus typing test are negative; No vaginal infection. Receives: Diagnostic Test: Microscopic examination of vaginal discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group
Nugent score is currently an internationally accepted diagnostic method for BV. Lactobacillus, Gardnerella vaginalis, bacterioid bacteria and campylobacter with variable staining are evaluated by Gram staining and semi-quantitative evaluation method. The total score is the sum of the scores of the above 4 bacteria. 0 to 3 points: normal; 4 ~ 6 points: intermediate BV; ≥7 points: BV
Measured: through study completion, an average of 2.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start9 Oct 2023 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion9 Oct 2026 (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 Uterine FibroidsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Yuan, Qianfoshan Hospital
- Investigators
- Lin Yuan, Ph.D., Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055114
- Sponsor's protocol ID
- qfsjyk15853128210
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan will be shared after the clinical trial is completed and the patent protection is obtained
Publications
Yang Q, Ciebiera M, Bariani MV, Ali M, Elkafas H, Boyer TG, Al-Hendy A. Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment. Endocr Rev. 2022 Jul 13;43(4):678-719. doi: 10.1210/endrev/bnab039.
PubMed 34741454El Andaloussi A, Chaudhry Z, Al-Hendy A, Ismail N. Uterine Fibroids: Bridging Genomic Defects and Chronic Inflammation. Semin Reprod Med. 2017 Nov;35(6):494-498. doi: 10.1055/s-0037-1607240. Epub 2017 Nov 3. No abstract available.
PubMed 29100237Zannotti A, Greco S, Pellegrino P, Giantomassi F, Delli Carpini G, Goteri G, Ciavattini A, Ciarmela P. Macrophages and Immune Responses in Uterine Fibroids. Cells. 2021 Apr 22;10(5):982. doi: 10.3390/cells10050982.
PubMed 33922329
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
- ClinicalTrials.gov ID
- NCT06055114
- Acronym / sponsor ID
- qfsjyk15853128210
- Conditions
- Uterine Fibroids
- Keywords
- uterine fibroids, vaginal microecology, cervical local immune function, childbearing age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lin YuanUniversity, hospital or other
- Study start
- 9 Oct 2023 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 26 Sep 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.
The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.
Detailed description
(1) In this study, 150 women of childbearing age who are diagnosed with uterine fibroids in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group; The differences of vaginal microenvironment and cervical local immune function are compared between 150 healthy women of childbearing age in the same period. (2) After the patients are enrolled, the general information (age, height, weight), menstrual status (age of menarche, menstrual period, cycle, bleeding pattern), clinical manifestations (abnormal uterine bleeding, infertility, abdominal pain), and previous medical history (hypertension, thyroid disease, etc.) of 150 patients with uterine fibroids will be collected. After the end of the first part of the experiment, 150 patients with uterine fibroids will be grouped according to vaginal microecological diagnosis, and the clinical characteristics of patients with uterine fibroids will be analyzed and compared.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: Microscopic examination of vaginal dischargeAge 20-49 years old; Premenopausal; Clinical diagnosis of uterine myoma; Cervical liquid-based cytology and human papillomavirus typing test are negative. |
| Healthy control group | – | Diagnostic Test: Microscopic examination of vaginal dischargeAge 20-49 years old; Premenopausal; Uterine B-ultrasonography is normal; Cervical liquid-based cytology and human papillomavirus typing test are negative; No vaginal infection. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) examined the uterine fibroid patients and healthy physical examination subjects.
Key inclusion criteria (11 listed)
- Age 20-49 years old
- Premenopausal
- Clinical diagnosis of uterine myoma
- Cervical liquid-based cytology and human papillomavirus typing test are negative
- Age 20-49 years old
Key exclusion criteria (7 listed)
- Used antibiotics, hormones, immunosuppressants and regulators within 1 month
- Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
- Pregnant, lactating or menstruating women
- Uterus and uterine adnexa have other lesions
- Used antibiotics, hormones, immunosuppressants and regulators within 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microscopic examination of vaginal dischargeUsing gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope. | Diagnostic test | Healthy control group, study group |
Primary outcome
Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group
Time frame: through study completion, an average of 2.5 year
Nugent score is currently an internationally accepted diagnostic method for BV. Lactobacillus, Gardnerella vaginalis, bacterioid bacteria and campylobacter with variable staining are evaluated by Gram staining and semi-quantitative evaluation method. The total score is the sum of the scores of the above 4 bacteria. 0 to 3 points: normal; 4 ~ 6 points: intermediate BV; ≥7 points: BV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Results publication: PubMed 34741454Yang Q, Ciebiera M, Bariani MV, Ali M, Elkafas H, Boyer TG, Al-Hendy A. Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment. Endocr Rev. 2022 Jul 13;43(4):678-719. doi: 10.1210/endrev/bnab039.
- Results publication: PubMed 29100237El Andaloussi A, Chaudhry Z, Al-Hendy A, Ismail N. Uterine Fibroids: Bridging Genomic Defects and Chronic Inflammation. Semin Reprod Med. 2017 Nov;35(6):494-498. doi: 10.1055/s-0037-1607240. Epub 2017 Nov 3. No abstract available.
- Results publication: PubMed 33922329Zannotti A, Greco S, Pellegrino P, Giantomassi F, Delli Carpini G, Goteri G, Ciavattini A, Ciarmela P. Macrophages and Immune Responses in Uterine Fibroids. Cells. 2021 Apr 22;10(5):982. doi: 10.3390/cells10050982.
- Individual participant dataSharing planned: Undecided. The plan will be shared after the clinical trial is completed and the patent protection is obtained
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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. This study is not recruiting at the moment.
Lin Yuan, Ph.D. principal investigator
Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by Lin Yuan.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Yuan, Ph.D. (0531-89269680, yuanl@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group (time frame: through study completion, an average of 2.5 year). 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 NCT06055114, which also lists 3 linked publications.
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 26 Sep 2023.