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

NCT ID: NCT06055114

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2026-10-09

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.

Conditions

Uterine Fibroids

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

study group

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

Microscopic examination of vaginal discharge

Intervention Type: DIAGNOSTIC_TEST

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.

Microscopic examination of vaginal discharge

Intervention Type: DIAGNOSTIC_TEST

Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lin Yuan

OTHER

Sponsor Role: lead

Responsible Party

Lin Yuan

technologist in charge

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lin Yuan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

Central Contacts

Lin Yuan, Ph.D.

Role: CONTACT

yuanl@sdfmu.edu.cn

0531-89269680

References

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.

Reference Type: RESULT

PMID: 34741454 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29100237 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33922329 (View on PubMed)

Other Identifiers

qfsjyk15853128210

Identifier Type: -

Identifier Source: org_study_id