Comprehensive tubal function assessment and personalized treatment for tubal factor infertility
Official title: Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
Run by Peking University People's Hospital · NCT07808229 · Data updated 2026-11-12
This study tests a new multi-dimensional way to diagnose tubal problems and to improve natural pregnancy after tubal surgery using a special anti-adhesion material and refined techniques.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07808229 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20-40 with infertility for at least 1 year and HSG-confirmed tubal pathology, scheduled for combined hysteroscopic and laparoscopic tubal surgery.
✕Probably not a fit
Patients with non-tubal infertility causes or those not undergoing surgery may not experience pregnancy benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial aims to develop and validate a comprehensive system that combines imaging, biomarkers, and surgical scoring to assess tubal function beyond traditional imaging. It also evaluates whether combining improved laparoscopic techniques with chitosan hydrogel reduces adhesions and improves 12-month natural pregnancy rates after surgery compared with historical standards. A predictive model using machine learning will be explored to forecast pregnancy outcomes within 12 months post-surgery. Eligible participants are women aged 20-40 with unilateral or bilateral hydrosalpinx or related tubal pathology and planned combined hysteroscopic-laparoscopic surgery. Outcomes include diagnostic accuracy, pregnancy rates, recurrence of adhesions, ectopic pregnancy risk, and model performance.
Why it matters
Potential benefit: If successful, patients could have higher chances of conceiving naturally after tubal surgery and clearer guidance on which patients will benefit most from surgical restoration.
How similar studies have gone: Previous surgical refinements have improved pregnancy rates, but standardized multi-dimensional assessment and integration with adjuvant materials are still being explored.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Xiaoming Yu
- Email: yuxiaomingmsn@163.com
- Phone: +086 18601139533
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.