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

Sponsor

Lin Yuan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06055114

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Diagnostic Test: Microscopic examination of vaginal discharge

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

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Oct 9, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Oct 9, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Lin Yuan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lin Yuan, technologist in charge, Qianfoshan Hospital

ClinicalTrials.gov Identifier:

NCT06055114

Other Study ID Numbers:

qfsjyk15853128210

First Posted:

Sep 26, 2023

Last Update Posted:

Sep 26, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lin Yuan, technologist in charge, Qianfoshan Hospital

uterine fibroids

vaginal microecology

cervical local immune function

childbearing age

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Sep 26, 2023