1Background & Objective
- Dilemma: CIN2+ in childbearing women — excision (LEEP/CKC) is effective but risks cervical insufficiency, preterm birth & delayed fertility.
- FUS: non-ionizing, non-invasive focused ultrasound — heats lesion >60°C, coagulates without harming surrounding tissue.
- Objective: evaluate FUS efficacy & fertility protection for cervical lesions in women needing family planning.
2Study Design
RCT
2-year follow-up
CIN2/3
TZ 1–2
ChiCTR
2300076739
FUS treatmentvs
standard care
- Setting: Third Affiliated Hospital of Zhengzhou University; ethics 2023-001.
- Inclusion: >18 y, histologic CIN2/CIN3 (TZ 1–2), family planning required.
- Exclusion: pregnancy/lactation · prior conization/LEEP/CKC · vaginal lavage <24 h · acute inflammation.
- Endpoints: HPV clearance, lesion regression, pregnancy & delivery outcomes, safety.
- Treatment: FUS session per protocol; quality control; data by dedicated physician.
- Data: full exam + psychological scale + recent records at each visit.
- Analysis: ITT + per-protocol; time-to-event for pregnancy outcomes.
3·6·12
month visits
18·24
month visits
8
scheduled visits
Focus >60°C→
Coagulation→
Lesion cleared
Outpatient·
No excision·
Fertility spared
FUS: single outpatient session, no cervical tissue removed.
3Follow-Up Schedule — 24 Months
BaselineFUS / exams
3 mo
6 mo
12 mo
18 mo
24 mopregnancy / delivery
- Visits: HPV, TCT, colposcopy, pathology, psychological scale at each timepoint.
- Fertility: pregnancy attempt after lesion regression; cervical biopsy before pregnancy & after delivery.
4Treatment Options for CIN2–3
| Method | Efficacy | Fertility impact | Notes |
|---|---|---|---|
| FUS (this trial) | 96.8% (prior) | non-invasive | no tissue removal |
| LEEP / CKC | effective | cervical insufficiency risk | preterm birth risk |
| Cryotherapy | effective | fewer pregnancy risks | large discharge; N2/CO2 supply |
Prior FUS reports: CIN1 efficacy ~90%, HPV clearance 85.7%; Zeng 2021 (n=154): efficacy 96.8%, recurrence 2.0%.
5Expected Value
96.8%
efficacy 3–6 mo
2.0%
recurrence
81.0%
HPV clearance
- Fertility preservation: no excision → lower preterm birth & cervical insufficiency risk.
- Efficacy: high lesion regression and HPV clearance in earlier series.
- Evidence gap: RCT-level data for childbearing women with CIN2/3 — this trial will provide it.
- Safety: no severe adverse reactions reported in prior FUS series.
- Established use: FUS already treats cervicitis & vulvovaginal disease.