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

Not yet recruiting

• Conditions: Uterine Fibroids

• Registration Number: NCT06055114
• Lead Sponsor: Lin Yuan

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.

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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-23
• Last Update Submitted: 2023-09-23
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26
• Study Start: 2023-10-09
• Primary Completion: 2026-05-01
• Study Completion: 2026-10-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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