Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies

Condition(s) studied

Investigational drug(s) / intervention(s)

Optimize the techniques and plans for fallopian tube reconstruction surgery: Comprehensive application of interventional recanalization and of anti-adhesion materials

Study summary

This clinical study aims to develop a comprehensive system to evaluate tubal function and to optimize individualized treatment strategies for patients with tubal factor infertility (caused by hydrosalpinx, obstruction, or adhesions). It will also assess whether integrating novel diagnostic tools, surgical techniques, and anti-adhesion materials can improve pregnancy outcomes.

The main questions it aims to answer are:

Can a new multi-dimensional evaluation system (combining imaging, ultrasound biomarkers, and surgical scoring) more accurately diagnose tubal damage compared to traditional hysterosalpingography (HSG) alone?

Does the combination of improved surgical techniques (laparoscopic recanalization) with a novel anti-adhesion material (chitosan hydrogel) increase the 12-month natural pregnancy rate after surgery compared to historical conventional surgery?

Can a prediction model using machine learning accurately predict natural pregnancy within 12 months after tubal surgery and help determine the optimal timing for transitioning to assisted reproductive technology (IVF/ICSI)?

Researchers will compare the new evaluation system against the traditional HSG approach, and the optimized surgical procedure with anti-adhesion material against historical data from conventional surgery.

Participants in this study will:

Undergo pre-operative imaging (HSG, 3D vascular ultrasound) and provide blood samples for biomarker testing (Part 1, n=120)

Receive either the new comprehensive tubal function assessment (combining HSG, ultrasound, intraoperative scoring, and biomarkers) or traditional HSG evaluation during the same hospital stay (Part 1)

Undergo the optimized laparoscopic tubal surgery with anti-adhesion material application (Part 2, n=120) and be followed up for 12 months to record natural pregnancy

Have their clinical data, imaging, and surgical findings used to develop and validate a predictive model for post-surgery natural pregnancy (Part 3, retrospective cohort of \~650 patients and prospective validation of \~200 patients)

Complete follow-up visits at 12 months post-surgery to confirm pregnancy status via ultrasound or medical records

Eligibility

Primary outcome measure(s)

• Pregnancy Rate — 12 months post-surgery

Trial sites (1)

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