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Clinical investigation of an intra-tubal contraceptive device composed of nitinol and silicone rubber: a pilot study

Clinical investigation of an intra-tubal contraceptive device composed of nitinol and silicone rubber: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002186
Enrollment
Unknown
Registered
2012-05-22
Start date
2009-03-06
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Contraception

Interventions

Inserted ITD-NTSR:Bilaterally Insert ITD-NTSR
Control:Bilaterally Injected phenol atabrine paste (PAP)

Sponsors

Shandong Provincial Family Planning Institute of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
28 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age 28-40 years; 2. Demonstrated prior fertility (>=one live birth); 3. Physical well-being; 4. Available for all study follow-up visits; 5. Comprehension of study participation risks and benefits; 6. Required long-term contraception or not suitable for pregnancy because of disease; 7. Was not enrolled in other clinical experiments during our study period.

Exclusion criteria

Exclusion criteria: 1. Positive pregnancy test; 2. Cervical or uterine neoplasia or neoplasia precursor; 3. Untreated acute cervicitis or history of acute pelvic inflammatory disease; 4. Uterine, cervical or adnexal pathologies, uterine or cervical neoplasia; 5. Unexplained abnormal uterine bleeding; 6. History of chronic pelvic pain, severe dysmenorrhea or severe dyspareunia; 7. Inability to comply with protocol requirements; 8. Monolateral tubal occlusion.

Design outcomes

Primary

MeasureTime frame
Inserted ITD-NTSR;Bilaterally Injected PA;

Countries

China

Contacts

Public ContactWang Lei-guang
sdwlg@sohu.com+86 18605313728/

Outcome results

None listed

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