Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000027617
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
19/07/2005
Date last updated
24/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of artificial insemination and IVF
Scientific title
A controlled trial of ovulation stimulation with intrauterine insemination versus in vitro ferilisation on clinical pregnancy rates in patient with idiopathic or mild male infertility
Secondary ID [1] 88 0
Royal Women's Hospital Research and Ethics Committee: Project 03/27
Secondary ID [2] 89 0
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN28780587
Universal Trial Number (UTN)
Trial acronym
IUIVF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 90 0
Condition category
Condition code
Reproductive Health and Childbirth 111 111 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ovarian stimulation with low dose rhFSH and randomised intrauterine insemination (IUI) or in vitro fertilisation (IVF).
Intervention code [1] 38 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 137 0
Clinical pregnancy (ultrasound fetal heart(s))
Timepoint [1] 137 0
Secondary outcome [1] 312 0
Economic analysis: relative cost per live birth pregnancy
Timepoint [1] 312 0

Eligibility
Key inclusion criteria
1) Infertility of 12 months or longer duration2) Primary or secondary infertility3)New patient or patient returning after an interval of longer than 1 year4) Female age 18-42, male age 18-80 years5) Detailed male and female partner clinical evaluation, investigation of semen quality and objective evidence of ovulation and tubal patency
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Coital disorders, including infrequent or mistimed coitus (<1 per 3 days during mid cycle)2) Tubal obstruction (one or both) or known ligation.3) Male infertility requiring ICSI: average sperm concentration less than 2 million/mL, progressive motility less than 25%, or abnormal morphology greater than 85% in two or more semen test performed within the previous 12 month in RWH andrology lab, sperm autoimmunity (IBT IgG or IgA antibodies on >50% of motile sperm together with blocked sperm mucus penetration4) untreated ovulatory disorders5)Ovarian endometrioma6)Currently treated patients

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)
Sequential numbered opaque envelopes containing the subject allocation are held by the head research nurse and opened at the time of ultraound scan showing either 2 or 3 leading follicles
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, adaptive biased coin randomization schedule stratified by women's age (35 or less and greater than 35) and number of follicles (2 or 3)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
812
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 152 0
Commercial sector/Industry
Name [1] 152 0
Serono Australia Ltd
Country [1] 152 0
Australia
Funding source category [2] 153 0
Commercial sector/Industry
Name [2] 153 0
Melbourne IVF
Country [2] 153 0
Australia
Primary sponsor type
Hospital
Name
Melbourne IVF
Address
Country
Australia
Secondary sponsor category [1] 108 0
None
Name [1] 108 0
Nil
Address [1] 108 0
Country [1] 108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 904 0
Royal Women's Hospital
Ethics committee address [1] 904 0
Ethics committee country [1] 904 0
Australia
Date submitted for ethics approval [1] 904 0
Approval date [1] 904 0
Ethics approval number [1] 904 0

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

Contacts
Principal investigator
Name 35929 0
Address 35929 0
Country 35929 0
Phone 35929 0
Fax 35929 0
Email 35929 0
Contact person for public queries
Name 9227 0
Dr HW Gordon Baker
Address 9227 0
University of Melbourne
Department of Obstetrics and Gynaecology
Royal Women's Hospital
Carlton VIC 3053
Country 9227 0
Australia
Phone 9227 0
+61 3 93442130
Fax 9227 0
+61 3 93471761
Email 9227 0
g.baker@unimelb.edu.au
Contact person for scientific queries
Name 155 0
Dr HW Gordon Baker
Address 155 0
University of Melbourne
Department of Obstetrics and Gynaecology
Royal Women's Hospital
Carlton VIC 3053
Country 155 0
Australia
Phone 155 0
+61 3 93442130
Fax 155 0
+61 3 93471761
Email 155 0
g.baker@unimelb.edu.au

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.