Clinical trial NCT06055114: Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Official title: Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Uterine Fibroids
Keywords: uterine fibroids
vaginal microecology
cervical local immune function
childbearing age
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) examined the uterine fibroid patients and healthy physical examination subjects.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group
timeFrame: through study completion, an average of 2.5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: Lin Yuan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.