NCT06055114

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Oct 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

September 10, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2026

Expected
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

September 10, 2023

Last Update Submit

September 23, 2023

Conditions

Uterine Fibroids

Keywords

uterine fibroidsvaginal microecologycervical local immune functionchildbearing age

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

study group

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

Diagnostic Test: Microscopic examination of vaginal discharge

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.

Diagnostic Test: Microscopic examination of vaginal discharge

Interventions

Microscopic examination of vaginal dischargeDIAGNOSTIC_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 groupstudy group

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 34741454RESULT

  • 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.

    PMID: 29100237RESULT

  • 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.

    PMID: 33922329RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Lin Yuan, Ph.D.

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yuan, Ph.D.

CONTACT

0531-89269680yuanl@sdfmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
technologist in charge

Study Record Dates

First Submitted

September 10, 2023

First Posted

September 26, 2023

Study Start

October 9, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 9, 2026

Last Updated

September 26, 2023

Record last verified: 2023-09