Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT05282095
Eligibility Criteria:
Inclusion Criteria:
* Female, 18 years of age or older and 45 years of age or younger, with a desire to conceive;
* Diagnosed with HSIL (CIN2) or HSIL (CIN2-3) via cervical tissue biopsy within the past 3 months, and has not undergone cervical surgery, physical, or medication treatment;
* The lesion area under colposcopy is less than 50% of the total cervical area within the past 3 months;
* Plans for 12-month follow-up observation for CIN2, with no surgical, physical, or medication treatment if the disease does not progress;
* Understands and voluntarily agrees to participate in the 12-month follow-up of this study, and signs the informed consent form.
Exclusion Criteria:
* Cervical status at the time of enrollment as determined by colposcopy within the past three months is Type III transformation zone;
* Pregnant or lactating;
* History of malignant reproductive tract tumors;
* History of hysterectomy, cervical surgery, or pelvic radiation therapy;
* Physical therapy to the cervix within 24 months prior to enrollment;
* The subject has a severe immune system disease that is active;
* Long-term use of contraceptives within 12 months prior to enrollment;
* Vaginal medication or irrigation within 72 hours prior to sampling (can re-enroll for sampling 3 days after cessation);
* Sexual intercourse within 24 hours prior to sampling (can re-enroll for sampling 24 hours after cessation);
* Received treatment for genital tract infections, HPV, or other STD pathogens within the past month (can re-enroll one month after cessation of treatment);
* Used antibiotics or vaginal microecological improvement products within the past month (can re-enroll one month after cessation of use);
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
45 Years
Study:
NCT05282095
Study Brief:
Protocol Section:
NCT05282095