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

Lin Yuan

Status: Not yet enrolling

Conditions: Uterine Fibroids

Treatments: Diagnostic Test: Microscopic examination of vaginal discharge

Study type: Observational

Funder types: Other

Identifiers

NCT06055114

qfsjyk15853128210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

study group

Description:

Age 20-49 years old; Premenopausal; Clinical diagnosis of uterine myoma; Cervical liquid-based cytology and human papillomavirus typing test are negative.

Treatment:

Diagnostic Test: Microscopic examination of vaginal discharge

Healthy control group

Description:

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.

Treatment:

Diagnostic Test: Microscopic examination of vaginal discharge