Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age

September 23, 2023 updated by: Lin Yuan
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) examined the uterine fibroid patients and healthy physical examination subjects.

Description

Inclusion Criteria:

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:

  • 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

Exclusion Criteria:

Exclusion criteria of the study group:

  • 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

Exclusion criteria of healthy control group:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
Age 20-49 years old; Premenopausal; Clinical diagnosis of uterine myoma; Cervical liquid-based cytology and human papillomavirus typing test are negative.
Diagnostic test: Microscopic examination of vaginal discharge
Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.
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.
Diagnostic test: Microscopic examination of vaginal discharge
Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Yuan

Investigators

  • Principal Investigator: Lin Yuan, Ph.D., Qianfoshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 9, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

October 9, 2026

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

September 23, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qfsjyk15853128210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan will be shared after the clinical trial is completed and the patent protection is obtained

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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