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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaoming Yu
yuxiaomingmsn@163.com
+086 18601139533
Time Frame
Start Date: 2026-08-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 240
Treatments
Experimental: Intervention Group (Trial Group)
Interventional Recanalization + Anti-adhesion Material
No_intervention: Control Group (Retrospective Group)
Traditional Salpingostomy
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov