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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055114
• Other study ID #: qfsjyk15853128210
• Status: Not yet recruiting
• Start date: October 9, 2023
• Est. completion date: October 9, 2026

Study information

• Verified date: September 2023
• Source: Qianfoshan Hospital
• Contact: Lin Yuan, Ph.D.
• Phone: 0531-89269680
• Email: yuanl[@]sdfmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 9, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lin Yuan

References & Publications (3)

El 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. — View Citation

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. Erratum In: Endocr Rev — View Citation

Zannotti 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 2.5 year