A clinical study of using copper intrauterine devices (IUDs) in emergency contraception

ISRCTN	ISRCTN24843309
DOI	https://doi.org/10.1186/ISRCTN24843309
Protocol serial number	A15046/96506
Sponsor	World Health Organization (WHO) (Switzerland)
Funder	World Health Organization (WHO) (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Shangchun Wu
Scientific

National Research Institute for Family Planning
12 Da Hui Si, Hai Dian Qu
Beijing
100081
China

Primary study design	Interventional
Study design	Prospective multicentre efficacy trial
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Copper intrauterine contraception for emergency contraception: a prospective multicentre study
Study objectives	The TCu380A IUD is highly effective as an emergency contraceptive.
Ethics approval(s)	1. China: Institutional Review Board of National Research Institute for Family Planning approved on the 20th September 2005 (ref: A15046; Protocol: 96506) 2. WHO Secretariat Committee on Research Involving Human Subjects All other centres will seek ethics approval before recruiting participants.
Health condition(s) or problem(s) studied	Contraception
Intervention	Eligible participants requesting EC up to 120 hours after unprotected intercourse and desiring long-term contraception with IUD, were given TCu380A IUD and followed for 12 months, including follow-up visits 1 and 3 months after the IUD insertion.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Efficacy of the TCu380A in parous and nulliparous Chinese women
Key secondary outcome measure(s)	1. Side effects of the TCu380A in parous and nulliparous Chinese women 2. Complications (such as upper genital tract infection) in the women who have IUD insertion for the purpose of emergency contraception 3. Continuation rate at one year of use
Completion date	15/01/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	2000
Key inclusion criteria	1. Requesting emergency contraception within 120 hour of unprotected intercourse 2. Regular menstrual cycles (24 to 42 days with no more than 5 days variation) 3. Having at least one spontaneous cycle before current cycle after recent discontinued hormonal contraception, abortion or delivery 4. Desire to use IUD as long term contraceptive 5. Available for follow up in one month, three months and 12 months 6. Negative pregnancy test 7. Aged 18 - 44 years
Key exclusion criteria	1. Suspected or confirmed pregnancy 2. Any episode of pelvic inflammatory disease (PID) or pelvic abscess in the 12 months preceding trial admission 3. Sexually transmitted infection (STI) within the past six months 4. Any evidence of STI in clinical or laboratory examination during screening 5. Multiple sexual partners 6. Known or suspected genital tract malignancy 7. Cervical or uterine malformations 8. Vaginal bleeding of unknown aetiology 9. Multiple uterine fibroids associated with previous menstrual anomalies 10. Clinical or laboratory evidence of anaemia (haemoglobin less than 9 g/l) 11. Unsure about the date of their last menstrual period (LMP needed for pregnancy risk assessment)
Date of first enrolment	01/07/1997
Date of final enrolment	15/01/2000

National Research Institute for Family Planning

Beijing
100081
China

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes