Clinical trial · Observational
Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
NCT06055114CI-TRIAL-00069939not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microscopic examination of vaginal discharge | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Diagnostic Test: Microscopic examination of vaginal discharge
- label
- 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.
- interventionNames
- Diagnostic Test: Microscopic examination of vaginal discharge
Primary outcomes (1)
- measure
- Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group
- timeFrame
- through study completion, an average of 2.5 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTYang 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. PMID 34741454
- RESULTEl 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. PMID 29100237
- RESULTZannotti 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. PMID 33922329