RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Peking University People's Hospital • ClinicalTrials.gov ID: NCT07808229

Registry updated: 2026-09-08

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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

Interventions

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

Eligibility criteria

Inclusion Criteria: * Age 20-40 years Duration of infertility ≥1 year * Hysterosalpingography (HSG) indicating unilateral or bilateral hydrosalpinx, obstruction, or adhesion of the fallopian tubes * Scheduled for combined hysteroscopic and laparoscopic surgery Signed informed consent Exclusion Criteria: * Coexisting other definite causes of infertility (e.g., severe male factor, ovarian reserve failure) * History of previous fallopian tube surgery * Severe concurrent medical or surgical conditions precluding surgery * Inability or unwillingness to comply with follow-up procedures * Non-natural conception (e.g., use of assisted reproductive technology) following surgery (applies to specific study arms, e.g., Study Part 2)

Conditions

Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility

Locations

Peking University People's Hospital — Beijing, Beijing Municipality, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment