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A clinical study of the Y-shaped copper/low-density polyethylene nanocomposite intrauterine devices

A clinical study of the Y-shaped copper/low-density polyethylene nanocomposite intrauterine devices

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15007256
Enrollment
Unknown
Registered
2015-09-28
Start date
2010-12-31
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

A:Y-shaped copper/low-density polyethylene nanocomposite intrauterine devices
B:TCu220C IUD

Sponsors

Family Planning Research Institute,Tongji Medical College,Huazhong University of Science Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
23 Years to 36 Years

Inclusion criteria

Inclusion criteria: 1. Parous women, aged 20-40 years; 2. Relying solely on the IUD for contraception; 3. BMI = weight kg / (height m) 2, between 19 to 30; 4. Regular menstrual cycle; 5. After the three months spontaneous vaginal delivery or Caesarean section six months or more. Breast-feeding postpartum women over six months and has been turning. After at least one normal menstrual abortion, medical abortion after 2 times the normal menstruation; 6. Hb>100g/L; 7. Normal outcome of general examination and gynaecological examination; 8. Without contraindication for IUD insertion; 9. Voluntary participation in the trial and signed informed consent; 10. Comply the clinical testing procedures.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the medical criteria; 2. Less than 48 hours postpartum; 3. Current pregnancy; 4. Current sexually transmitted disease or purulent cervicitis; 5. Congenital malformation of the uterus, multiple uterine fibroids; 6. Genital tract bleeding other than that attributable to menses; 7. Clinical or laboratory evidence of anaemia or endometrial cancer; 8. Allergy to copper; 9. Severe acute and chronic systemic diseases, such as heart failure, severe anemia, diseases and acute phase of various diseases and the like; cardiovascular, gastrointestinal, liver, kidney, respiratory system disease history or an existing above.

Design outcomes

Primary

MeasureTime frame
pregnancy;fall off;Menstrual conditions;take-off rate due to symptom;Withdraw;

Countries

China

Contacts

Public ContactChanghong Zhu
reprodcentre@163.com+86 15902748720

Outcome results

None listed

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