Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001303831
Ethics application status
Approved
Date submitted
10/06/2008
Date registered
17/12/2012
Date last updated
27/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of Fallopian Sperm Perfusion in intrauterine insemination in improving pregnancy outcomes
Scientific title
Fallopian Sperm Perfusion versus intrauterine insemination for couples with unexplained infertility in improving pregnancy outcomes
Secondary ID [1] 262977 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 3250 0
Condition category
Condition code
Reproductive Health and Childbirth 3414 3414 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fallopian Sperm Perfusion - a technique of intrauterine insemination using a catheter with a balloon to reduce loss and also using 4 ml of insemination fluid with the sperm -to ensure that some of the sperm are in the fallopian tube. Only one cycle. It takes about 10 mins to complete.
Intervention code [1] 2991 0
Treatment: Other
Comparator / control treatment
intrauterine insemination involves insemination of the male partners semen directly into the uterine cavity. It only occurs at the time of ovulation usually about day 13 and 14 and it takes about 10 minutes to complete.
Patients undergo treatment only once.
Control group
Active

Outcomes
Primary outcome [1] 4311 0
live birth rate - delivery after 24 hours of live born neonate.
Timepoint [1] 4311 0
one year
Secondary outcome [1] 7264 0
miscarriage - loss of pregnancy up to 24 weeks after a positive pregnancy test at 6 weeks
Timepoint [1] 7264 0
one year

Eligibility
Key inclusion criteria
unexplained infertility more than one year
Minimum age
20 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
tubal infertility, male infertility

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
computer generated sequence in serially numbered opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2006
Actual
17/07/2006
Date of last participant enrolment
Anticipated
1/02/2012
Actual
1/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
417
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 7387 0
New Zealand
State/province [1] 7387 0

Funding & Sponsors
Funding source category [1] 286030 0
Charities/Societies/Foundations
Name [1] 286030 0
Auckland District Health Board A+ TRUST funded the cost of the catheters
Country [1] 286030 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Room 51, Level 12, Department of Obstetrics and Gynaecology (O&G)
Auckland City Hospital, Park Rd, Auckland 1042
Country
New Zealand
Secondary sponsor category [1] 3116 0
None
Name [1] 3116 0
Address [1] 3116 0
Country [1] 3116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5504 0
Ministry of Health
Ethics committee address [1] 5504 0
Ethics committee country [1] 5504 0
New Zealand
Date submitted for ethics approval [1] 5504 0
Approval date [1] 5504 0
01/12/2005
Ethics approval number [1] 5504 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28660 0
Prof Cynthia Farquhar
Address 28660 0
Dept of Obstetrics and Gynaecology

Private Bag 92019
University of Auckland
Auckland 1011
Country 28660 0
New Zealand
Phone 28660 0
+6493737599
Fax 28660 0
Email 28660 0
[email protected]
Contact person for public queries
Name 11817 0
Cynthia Farquhar
Address 11817 0
Room 51, Level 12, Department of O&G
University of Auckland, Auckland City Hospital, Park Rd, Auckland 1011
Country 11817 0
New Zealand
Phone 11817 0
+6493737599
Fax 11817 0
Email 11817 0
[email protected]
Contact person for scientific queries
Name 2745 0
Cynthia Farquhar
Address 2745 0
Room 51, Level 12, Department of O&G
University of Auckland, Auckland City Hospital, Park Rd, 1011
Country 2745 0
New Zealand
Phone 2745 0
+6493737599
Fax 2745 0
+6493035969
Email 2745 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.