Development and experimental study on the new three-dimensional and reticular intrauterine device (NTDR-IUD) composed of nitinol and silicone rubber

Clinical investigation of an new three-dimensional and reticular intrauterine device (NTDR-IUD) composed of nitinol and silicone rubber

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002183

Enrollment

Unknown

Registered

2012-05-17

Start date

2011-02-03

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

NTDR-IUD group:Use NTDR-IUD

control:traditional IUD

Eligibility

Sex/Gender

Female

Age

24 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age 24-40 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.

Design outcomes

Primary

Measure	Time frame
Contraceptive effect;	—

Countries

China

Contacts

Public ContactQiu Yi

qiuyi987@sina.com+86 13964006672

Outcome results

None listed

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