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Evaluate Safety and Efficacy of New Fallopian Tube Embolization Devices before Embryo Transfer in Infertile Patients with Hydrosalpinx: A Prospective, Multicenter, Single-arm Clinical Trial

Evaluate Safety and Efficacy of New Fallopian Tube Embolization Devices before Embryo Transfer in Infertile Patients with Hydrosalpinx: A Prospective, Multicenter, Single-arm Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091850
Enrollment
Unknown
Registered
2024-11-05
Start date
2023-02-07
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hydrosalpinx

Interventions

Single arm group:Fallopian Tube embolization

Sponsors

Obstertrics&Gynecology Hosptial of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
23 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 23-40 years; 2. Salpingography for diagnosis of Unilateral or bilateral hydrosalpinx 3. The uterine cavity is intact 4. Planned IVF-ET assisted pregnancy or conceived naturally 5. The subject can understand the purpose of the trial, voluntarily participate and sign the informed consent form and express recognition of the risks and benefits described in the informed consent form and accept follow-up visits

Exclusion criteria

Exclusion criteria: 1. Gynecological underlying diseases that affect interventional surgery, such as endometrial lesions, uterine malformations, and uterine fibroids 2. Patients with individuals infected with acute or subacute inflammation of both internal and external genitalia. 3. Patients with severe heart brain and lung disease and severe liver and kidney dysfunction lead to cannot tolerate surgery 4. Patients with unexplained persistent uterine bleeding 5. Individuals with menstrual cycle disorders 6. The patient has a clear history of allergies to platinum-tungsten alloy 7. Patients with unstable hyperthyroidism treatment 8. Asthma patients in the onset period; 9. Patients with a history of repeated failed embolization device implantation; 10. Diagnosed with severe diseases such as advanced cancer patients who life expectancy less than 12 months could not complete the study follow-up 11. Women who are pregnant or breastfeeding 12. Is participating in any other clinical trial 13. Patients with poor compliance and unable to follow up as planned; 14. 14Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Complete occlusion rate of target fallopian tubes;

Secondary

MeasureTime frame
Implant success rate;

Countries

China

Contacts

Public ContactGuofu Zhang

Obstertrics&Gynecology Hosptial of Fudan University

guofuzh@fudan.edu.cn+86 139 1610 4313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026