Uterine Fibroids Clinical Trial
Official title:
Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Lin Yuan |
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
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 |
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