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NCT Number: NCT06055114

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.

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Key information

Age range

20 year–49 year

Sex eligibility

Female

Study type

Observational

About this study

(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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microscopic examination of vaginal discharge

Diagnostic Test

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

Primary outcomes

  1. Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group

    Time frame: through study completion, an average of 2.5 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Yuan, Ph.D.

CONTACT

[email protected]

0531-89269680

Sponsors and collaborators

Lead sponsor

Lin Yuan

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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