Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor InfertilityNCT07808229
Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
A study testing Optimize the techniques and plans for fallopian tube reconstruction surgery in people with Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility, run by Peking University People's Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility
- What is being tested?
- Optimize the techniques and plans for fallopian tube reconstruction surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Peking University People's Hospital, +86 010 88324350, yuxiaomingmsn@163.com
About this study
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:
Read more
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
Read the detailed description
- . Background and Rationale Tubal factor infertility (TFI) accounts for approximately 25%-35% of female infertility cases worldwide, predominantly caused by hydrosalpinx, tubal obstruction, peritubal adhesions, and structural abnormalities. Although assisted reproductive technologies (ART) have advanced considerably, tubal pathology-particularly hydrosalpinx-compromises IVF outcomes through embryotoxic fluid backflow and reduced endometrial receptivity. Concurrently, shifting demographic trends and fertility policy changes have increased patient demand for surgical restoration of natural fertility as an alternative to ART. Recent innovations in reproductive surgery, including refined four-step fimbrioplasty and modified tubotubal anastomosis, have improved pregnancy rates. However, two major challenges persist: (1) high postoperative recurrence of adhesions and hydrosalpinx, and (2) significant ectopic pregnancy risk. More critically, the lack of a standardized, objective, and comprehensive system for evaluating tubal functional reserve severely limits appropriate surgical candidate selection and outcome prediction. Current clinical practice relies heavily on hysterosalpingography (HSG), which provides only anatomical patency information without assessing mucosal health, peritubal environment, or functional integrity. This study addresses these gaps by proposing a multi-dimensional, multi-temporal assessment framework integrating imaging, molecular biomarkers, and intraoperative findings. It further aims to optimize surgical techniques using a novel anti-adhesion biomaterial and to develop machine learning-based predictive models to guide individualized treatment decisions for TFI patients.
- Study Design Overview The investigation comprises three integrated components: Component 1 (Diagnostic Accuracy Study) : A prospective, single-center diagnostic trial enrolling 120 TFI patients. Each participant serves as their own control, undergoing both the novel multi-dimensional assessment strategy (Strategy A) and conventional HSG-only strategy (Strategy B), with intraoperative laparoscopy with chromopertubation as the reference standard. Component 2 (Interventional Trial with Historical Control) : A single-arm interventional trial with historical controls, enrolling 120 patients receiving optimized laparoscopic surgery with chitosan hydrogel application (experimental group), compared with 120 historical controls who underwent conventional surgery without the novel anti-adhesion intervention. The primary endpoint is the 12-month natural pregnancy rate. Component 3 (Prediction Model Study) : A bidirectional cohort study comprising a retrospective development cohort (~650 patients, 2010-2024) and a prospective validation cohort (~200 patients, 2026-2028), developing and validating logistic regression and XGBoost machine learning models for predicting 12-month natural pregnancy following tubal surgery.
- Component 1: Tubal Function Assessment System-Technical Details 3.1 Preoperative Multi-Modal Imaging and Biomarkers Quantitative HSG Scoring: All participants undergo standardized oil-based contrast HSG (Lipiodol). Beyond patency assessment, systematic scoring includes: (a) fimbrial morphology (mucosal bridges, accessory ostia); (b) ampullary morphology (diverticula, dilatation, strictures); and (c) contrast spillage pattern (uniform vs. localized peritoneal dispersion) as an indirect adhesion indicator. A 0-3 graded scoring system is applied, incorporating hydrosalpinx diameter, tubal wall rigidity, and adhesion extent. Three-Dimensional Vascular Ultrasound: Transvaginal 3D power Doppler ultrasound quantifies tubal vascularization and perfusion. Color Doppler flow imaging parameters-peak systolic velocity (PSV), end-diastolic velocity (EDV), resistance index (RI), and pulsatility index (PI)-are measured at the tubal wall and fimbrial regions. Fimbrial blood flow is semi-quantitatively graded as Grade 0 (no flow), Grade 1 (sparse punctate), or Grade 2 (abundant linear/reticular). Molecular Biomarkers: Fasting venous blood samples are collected preoperatively. Serum CA125, VEGF, and IL-6 levels are measured using standardized ELISA protocols, selected for their established roles in peritoneal inflammation, angiogenesis, and endometriosis-associated tubal pathology. 3.2 Intraoperative Reference Standard and Integrated Scoring Laparoscopic Evaluation: Systematic pelvic inspection is performed, with pelvic adhesions quantified using the revised American Fertility Society (r-AFS) classification. Tubal assessment includes serosal status, morphology (dilatation, tortuosity, hydrosalpinx degree), and fimbrial architecture. Chromopertubation with methylene blue classifies fimbrial efflux patterns as free flow, impaired flow, or no flow. Hysteroscopic and Salpingoscopic Evaluation: Diagnostic hysteroscopy assesses uterine cavity and tubal ostia. For tubes with abnormal chromopertubation, fiberoptic salpingoscopy evaluates mucosal fold architecture, intraluminal adhesions, polyps, vasculature, and staining patterns, generating an intraluminal pathology score. Integrated Composite Score: All quantitative data (HSG score, ultrasound PI/RI/flow grade, biomarkers, r-AFS score, salpingoscopy score) are entered into a unified electronic case report form. A weighted composite tubal function score is derived via exploratory factor analysis, categorizing dysfunction into Grades I-V (mild to severe), with diagnostic performance evaluated against intraoperative laparoscopy as the reference standard.
- Component 2: Surgical Technique Optimization-Technical Details 4.1 Anti-Adhesion Biomaterial: Chitosan Hydrogel The investigational device is medical-grade chitosan hydrogel (NMPA Class III-approved). Its multi-mechanistic action includes: Physical Barrier: Forms a transparent, flexible gel film over surgical surfaces, mechanically isolating traumatized tissue planes to prevent fibrin deposition. Mild Hemostasis: Positively charged chitosan interacts with negatively charged erythrocyte membranes, promoting platelet aggregation and reducing hematoma formation-a key adhesion initiator. Biological Modulation: Selectively promotes epithelial and endothelial cell proliferation while inhibiting fibroblast overgrowth via downregulation of TGF-β1 and other pro-fibrotic cytokines, reducing pathological scar formation. Mucosal Regeneration: Degradation products (N-acetylglucosamine and glucosamine) serve as substrates for normal tissue growth, promoting tubal mucosal epithelial repair. 4.2 Optimized Surgical Procedure (Experimental Group) The procedure is performed under combined laparoscopic and hysteroscopic guidance, with the following key modifications: Pelvic Adhesiolysis: Precise adhesiolysis using electrosurgery or cold scissors restores normal tubo-ovarian anatomy, with meticulous hemostasis. Fimbrioplasty/Salpingostomy: A modified "four-step" fimbrioplasty is performed for hydrosalpinx, with chromopertubation confirming patency. Combined Laparoscopic-Hysteroscopic Recanalization: Under hysteroscopic guidance, a hydrophilic-coated guidewire is advanced through the tubal lumen under direct laparoscopic visualization until the tip is visible at the fimbrial end. Critical modification: Prior to insertion, chitosan hydrogel is uniformly applied to the distal 10-15 cm of the guidewire, enabling direct intraluminal deposition of the anti-adhesion agent during recanalization. Comprehensive Anti-Adhesion Application: (a) 3-5 mL of injectable chitosan hydrogel is infused through the guiding catheter to fully distend the tubal lumen; (b) chitosan hydrogel is uniformly sprayed over the reconstructed fimbrial end, the entire tubal serosal surface, and all other pelvic surgical surfaces (ovaries, uterine wall, pelvic sidewall). 4.3 Control Group Procedure (Historical) Control patients underwent conventional tubal surgery (salpingostomy or recanalization) without the guidewire-mediated intraluminal chitosan application. Anti-adhesion material, if used, was applied only to the peritoneal cavity and peri-tubal surfaces, without targeted intraluminal instillation.
- Component 3: Prediction Model Development and Validation 5.1 Candidate Predictors Candidate predictors are selected based on biological plausibility and clinical relevance, encompassing five domains: ① Demographic and baseline characteristics (age, BMI, infertility type and duration); ② Ovarian reserve (baseline AMH); ③ Tubal pathology characteristics (preoperative HSG score, 3D ultrasound parameters [PI, RI, flow grade], intraoperative composite tubal function score, r-AFS pelvic adhesion score); ④ Molecular biomarkers (serum VEGF, IL-6, CA125); ⑤ Surgical factors (procedure type: salpingostomy vs. recanalization vs. combined). 5.2 Model Development and Validation Strategy Model Development: The development cohort (n=650) is randomly partitioned into training (70%) and internal test (30%) sets. Logistic Regression: Variable selection proceeds via univariate analysis (P<0.1 for entry) followed by LASSO regression with 10-fold cross-validation to select the optimal penalty parameter (λ), yielding the most parsimonious model. XGBoost Machine Learning Model: Implemented using all candidate variables, with grid search and cross-validation for hyperparameter tuning, and built-in feature importance ranking. Model Validation: Internal Validation: Bootstrap resampling (1,000 iterations) is performed on the training set to correct for optimism and assess stability. External Validation: Temporal validation using the prospective single-center cohort (n=200) and spatial validation using multi-center prospective data assess generalizability across time and institutions. Performance Evaluation: Discrimination is assessed by AUC with 95% CIs, along with accuracy, sensitivity, specificity, and predictive values at the optimal Youden-index threshold. Calibration is evaluated via calibration plots with loess smoothing and the Hosmer-Lemeshow test. Clinical utility is quantified using decision curve analysis (DCA) across a range of threshold probabilities.
- Being tested
- Optimize the techniques and plans for fallopian tube reconstruction surgery
- Keywords
- Hydrosalpinx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimize the techniques and plans for fallopian tube reconstruction surgeryProcedure or surgery
Comprehensive application of interventional recanalization and of anti-adhesion materials
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Trial Group) | Experimental | Interventional Recanalization + Anti-adhesion Material Receives: Procedure: Optimize the techniques and plans for fallopian tube reconstruction surgery |
| Control Group (Retrospective Group) | No intervention | Traditional Salpingostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu xiaoming, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808229
- Sponsor's protocol ID
- 2025PHB423-001
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nakagawa K, Inoue M, Nishi Y, Sugiyama R, Motoyama K, Kuribayashi Y, Akira S, Sugiyama R. A new evaluation score that uses salpingoscopy to reflect fallopian tube function in infertile women. Fertil Steril. 2010 Dec;94(7):2753-7. doi: 10.1016/j.fertnstert.2010.03.012. Epub 2010 Apr 18.
PubMed 20403593de Groot AN, van Dongen PW, Vree TB, Eskes TK. Oral administration of methylergometrine shows a late and unpredictable effect on the non-pregnant human menstruating uterus. Eur J Obstet Gynecol Reprod Biol. 1995 Jun;60(2):101-7. doi: 10.1016/0028-2243(95)02100-7.
PubMed 7641959Sotrel G. Is surgical repair of the fallopian tubes ever appropriate? Rev Obstet Gynecol. 2009 Summer;2(3):176-85.
PubMed 19826575Huang C, He X, Luo W, Chen H, Huang Y. Combined chitosan and Dan-shen injection for long-term tubal patency in fallopian tube recanalization for infertility. Drug Deliv Transl Res. 2019 Aug;9(4):738-747. doi: 10.1007/s13346-018-00611-0.
PubMed 30610502Ding N, Zhang J, Wang P, Wang F. A novel machine learning model for predicting clinical pregnancy after laparoscopic tubal anastomosis. BMC Pregnancy Childbirth. 2023 Jul 24;23(1):537. doi: 10.1186/s12884-023-05854-5.
PubMed 37488509Marana R, Catalano GF, Muzii L, Caruana P, Margutti F, Mancuso S. The prognostic role of salpingoscopy in laparoscopic tubal surgery. Hum Reprod. 1999 Dec;14(12):2991-5. doi: 10.1093/humrep/14.12.2991.
PubMed 10601084Camus E, Poncelet C, Goffinet F, Wainer B, Merlet F, Nisand I, Philippe HJ. Pregnancy rates after in-vitro fertilization in cases of tubal infertility with and without hydrosalpinx: a meta-analysis of published comparative studies. Hum Reprod. 1999 May;14(5):1243-9. doi: 10.1093/humrep/14.5.1243.
PubMed 10325271
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
- ClinicalTrials.gov ID
- NCT07808229
- Acronym / sponsor ID
- 2025PHB423-001
- Keywords
- Hydrosalpinx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- . Background and Rationale Tubal factor infertility (TFI) accounts for approximately 25%-35% of female infertility cases worldwide, predominantly caused by hydrosalpinx, tubal obstruction, peritubal adhesions, and structural abnormalities. Although assisted reproductive technologies (ART) have advanced considerably, tubal pathology-particularly hydrosalpinx-compromises IVF outcomes through embryotoxic fluid backflow and reduced endometrial receptivity. Concurrently, shifting demographic trends and fertility policy changes have increased patient demand for surgical restoration of natural fertility as an alternative to ART. Recent innovations in reproductive surgery, including refined four-step fimbrioplasty and modified tubotubal anastomosis, have improved pregnancy rates. However, two major challenges persist: (1) high postoperative recurrence of adhesions and hydrosalpinx, and (2) significant ectopic pregnancy risk. More critically, the lack of a standardized, objective, and comprehensive system for evaluating tubal functional reserve severely limits appropriate surgical candidate selection and outcome prediction. Current clinical practice relies heavily on hysterosalpingography (HSG), which provides only anatomical patency information without assessing mucosal health, peritubal environment, or functional integrity. This study addresses these gaps by proposing a multi-dimensional, multi-temporal assessment framework integrating imaging, molecular biomarkers, and intraoperative findings. It further aims to optimize surgical techniques using a novel anti-adhesion biomaterial and to develop machine learning-based predictive models to guide individualized treatment decisions for TFI patients.
- Study Design Overview The investigation comprises three integrated components: Component 1 (Diagnostic Accuracy Study) : A prospective, single-center diagnostic trial enrolling 120 TFI patients. Each participant serves as their own control, undergoing both the novel multi-dimensional assessment strategy (Strategy A) and conventional HSG-only strategy (Strategy B), with intraoperative laparoscopy with chromopertubation as the reference standard. Component 2 (Interventional Trial with Historical Control) : A single-arm interventional trial with historical controls, enrolling 120 patients receiving optimized laparoscopic surgery with chitosan hydrogel application (experimental group), compared with 120 historical controls who underwent conventional surgery without the novel anti-adhesion intervention. The primary endpoint is the 12-month natural pregnancy rate. Component 3 (Prediction Model Study) : A bidirectional cohort study comprising a retrospective development cohort (~650 patients, 2010-2024) and a prospective validation cohort (~200 patients, 2026-2028), developing and validating logistic regression and XGBoost machine learning models for predicting 12-month natural pregnancy following tubal surgery.
- Component 1: Tubal Function Assessment System-Technical Details 3.1 Preoperative Multi-Modal Imaging and Biomarkers Quantitative HSG Scoring: All participants undergo standardized oil-based contrast HSG (Lipiodol). Beyond patency assessment, systematic scoring includes: (a) fimbrial morphology (mucosal bridges, accessory ostia); (b) ampullary morphology (diverticula, dilatation, strictures); and (c) contrast spillage pattern (uniform vs. localized peritoneal dispersion) as an indirect adhesion indicator. A 0-3 graded scoring system is applied, incorporating hydrosalpinx diameter, tubal wall rigidity, and adhesion extent. Three-Dimensional Vascular Ultrasound: Transvaginal 3D power Doppler ultrasound quantifies tubal vascularization and perfusion. Color Doppler flow imaging parameters-peak systolic velocity (PSV), end-diastolic velocity (EDV), resistance index (RI), and pulsatility index (PI)-are measured at the tubal wall and fimbrial regions. Fimbrial blood flow is semi-quantitatively graded as Grade 0 (no flow), Grade 1 (sparse punctate), or Grade 2 (abundant linear/reticular). Molecular Biomarkers: Fasting venous blood samples are collected preoperatively. Serum CA125, VEGF, and IL-6 levels are measured using standardized ELISA protocols, selected for their established roles in peritoneal inflammation, angiogenesis, and endometriosis-associated tubal pathology. 3.2 Intraoperative Reference Standard and Integrated Scoring Laparoscopic Evaluation: Systematic pelvic inspection is performed, with pelvic adhesions quantified using the revised American Fertility Society (r-AFS) classification. Tubal assessment includes serosal status, morphology (dilatation, tortuosity, hydrosalpinx degree), and fimbrial architecture. Chromopertubation with methylene blue classifies fimbrial efflux patterns as free flow, impaired flow, or no flow. Hysteroscopic and Salpingoscopic Evaluation: Diagnostic hysteroscopy assesses uterine cavity and tubal ostia. For tubes with abnormal chromopertubation, fiberoptic salpingoscopy evaluates mucosal fold architecture, intraluminal adhesions, polyps, vasculature, and staining patterns, generating an intraluminal pathology score. Integrated Composite Score: All quantitative data (HSG score, ultrasound PI/RI/flow grade, biomarkers, r-AFS score, salpingoscopy score) are entered into a unified electronic case report form. A weighted composite tubal function score is derived via exploratory factor analysis, categorizing dysfunction into Grades I-V (mild to severe), with diagnostic performance evaluated against intraoperative laparoscopy as the reference standard.
- Component 2: Surgical Technique Optimization-Technical Details 4.1 Anti-Adhesion Biomaterial: Chitosan Hydrogel The investigational device is medical-grade chitosan hydrogel (NMPA Class III-approved). Its multi-mechanistic action includes: Physical Barrier: Forms a transparent, flexible gel film over surgical surfaces, mechanically isolating traumatized tissue planes to prevent fibrin deposition. Mild Hemostasis: Positively charged chitosan interacts with negatively charged erythrocyte membranes, promoting platelet aggregation and reducing hematoma formation-a key adhesion initiator. Biological Modulation: Selectively promotes epithelial and endothelial cell proliferation while inhibiting fibroblast overgrowth via downregulation of TGF-β1 and other pro-fibrotic cytokines, reducing pathological scar formation. Mucosal Regeneration: Degradation products (N-acetylglucosamine and glucosamine) serve as substrates for normal tissue growth, promoting tubal mucosal epithelial repair. 4.2 Optimized Surgical Procedure (Experimental Group) The procedure is performed under combined laparoscopic and hysteroscopic guidance, with the following key modifications: Pelvic Adhesiolysis: Precise adhesiolysis using electrosurgery or cold scissors restores normal tubo-ovarian anatomy, with meticulous hemostasis. Fimbrioplasty/Salpingostomy: A modified "four-step" fimbrioplasty is performed for hydrosalpinx, with chromopertubation confirming patency. Combined Laparoscopic-Hysteroscopic Recanalization: Under hysteroscopic guidance, a hydrophilic-coated guidewire is advanced through the tubal lumen under direct laparoscopic visualization until the tip is visible at the fimbrial end. Critical modification: Prior to insertion, chitosan hydrogel is uniformly applied to the distal 10-15 cm of the guidewire, enabling direct intraluminal deposition of the anti-adhesion agent during recanalization. Comprehensive Anti-Adhesion Application: (a) 3-5 mL of injectable chitosan hydrogel is infused through the guiding catheter to fully distend the tubal lumen; (b) chitosan hydrogel is uniformly sprayed over the reconstructed fimbrial end, the entire tubal serosal surface, and all other pelvic surgical surfaces (ovaries, uterine wall, pelvic sidewall). 4.3 Control Group Procedure (Historical) Control patients underwent conventional tubal surgery (salpingostomy or recanalization) without the guidewire-mediated intraluminal chitosan application. Anti-adhesion material, if used, was applied only to the peritoneal cavity and peri-tubal surfaces, without targeted intraluminal instillation.
- Component 3: Prediction Model Development and Validation 5.1 Candidate Predictors Candidate predictors are selected based on biological plausibility and clinical relevance, encompassing five domains: ① Demographic and baseline characteristics (age, BMI, infertility type and duration); ② Ovarian reserve (baseline AMH); ③ Tubal pathology characteristics (preoperative HSG score, 3D ultrasound parameters [PI, RI, flow grade], intraoperative composite tubal function score, r-AFS pelvic adhesion score); ④ Molecular biomarkers (serum VEGF, IL-6, CA125); ⑤ Surgical factors (procedure type: salpingostomy vs. recanalization vs. combined). 5.2 Model Development and Validation Strategy Model Development: The development cohort (n=650) is randomly partitioned into training (70%) and internal test (30%) sets. Logistic Regression: Variable selection proceeds via univariate analysis (P<0.1 for entry) followed by LASSO regression with 10-fold cross-validation to select the optimal penalty parameter (λ), yielding the most parsimonious model. XGBoost Machine Learning Model: Implemented using all candidate variables, with grid search and cross-validation for hyperparameter tuning, and built-in feature importance ranking. Model Validation: Internal Validation: Bootstrap resampling (1,000 iterations) is performed on the training set to correct for optimism and assess stability. External Validation: Temporal validation using the prospective single-center cohort (n=200) and spatial validation using multi-center prospective data assess generalizability across time and institutions. Performance Evaluation: Discrimination is assessed by AUC with 95% CIs, along with accuracy, sensitivity, specificity, and predictive values at the optimal Youden-index threshold. Calibration is evaluated via calibration plots with loess smoothing and the Hosmer-Lemeshow test. Clinical utility is quantified using decision curve analysis (DCA) across a range of threshold probabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Trial Group) | Experimental | Procedure: Optimize the techniques and plans for fallopian tube reconstruction surgeryInterventional Recanalization + Anti-adhesion Material |
| Control Group (Retrospective Group) | No intervention | –Traditional Salpingostomy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimize the techniques and plans for fallopian tube reconstruction surgeryComprehensive application of interventional recanalization and of anti-adhesion materials | Procedure or surgery | Intervention Group (Trial Group) |
Primary outcome
Pregnancy Rate
Time frame: 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 20403593Nakagawa K, Inoue M, Nishi Y, Sugiyama R, Motoyama K, Kuribayashi Y, Akira S, Sugiyama R. A new evaluation score that uses salpingoscopy to reflect fallopian tube function in infertile women. Fertil Steril. 2010 Dec;94(7):2753-7. doi: 10.1016/j.fertnstert.2010.03.012. Epub 2010 Apr 18.
- Background: PubMed 7641959de Groot AN, van Dongen PW, Vree TB, Eskes TK. Oral administration of methylergometrine shows a late and unpredictable effect on the non-pregnant human menstruating uterus. Eur J Obstet Gynecol Reprod Biol. 1995 Jun;60(2):101-7. doi: 10.1016/0028-2243(95)02100-7.
- Background: PubMed 19826575Sotrel G. Is surgical repair of the fallopian tubes ever appropriate? Rev Obstet Gynecol. 2009 Summer;2(3):176-85.
- Background: PubMed 30610502Huang C, He X, Luo W, Chen H, Huang Y. Combined chitosan and Dan-shen injection for long-term tubal patency in fallopian tube recanalization for infertility. Drug Deliv Transl Res. 2019 Aug;9(4):738-747. doi: 10.1007/s13346-018-00611-0.
- Background: PubMed 37488509Ding N, Zhang J, Wang P, Wang F. A novel machine learning model for predicting clinical pregnancy after laparoscopic tubal anastomosis. BMC Pregnancy Childbirth. 2023 Jul 24;23(1):537. doi: 10.1186/s12884-023-05854-5.
- Background: PubMed 10601084Marana R, Catalano GF, Muzii L, Caruana P, Margutti F, Mancuso S. The prognostic role of salpingoscopy in laparoscopic tubal surgery. Hum Reprod. 1999 Dec;14(12):2991-5. doi: 10.1093/humrep/14.12.2991.
- Background: PubMed 10325271Camus E, Poncelet C, Goffinet F, Wainer B, Merlet F, Nisand I, Philippe HJ. Pregnancy rates after in-vitro fertilization in cases of tubal infertility with and without hydrosalpinx: a meta-analysis of published comparative studies. Hum Reprod. 1999 May;14(5):1243-9. doi: 10.1093/humrep/14.5.1243.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimize the techniques and plans for fallopian tube reconstruction surgery in people with Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Yu (+086 18601139533, yuxiaomingmsn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808229, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.