Contact information
Type
Scientific
Primary contact
Dr Gordon Baker
ORCID ID
Contact details
University of Melbourne Department of Obstetrics and Gynaecology
Royal Women's Hospital
132 Grattan Street
Carlton
Victoria
3053
Australia
+61 (0)3 93442130
g.baker@unimelb.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03/07; ACTRN12605000027617
Study information
Scientific title
Acronym
Study hypothesis
Added 16/12/2008:
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.
Ethics approval
Royal Women's Hospital Research and Ethics Committee, ref: 03/27
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Idiopathic or mild male infertility
Intervention
Standard IVF, or low dose follicle stimulating hormone (FSH) with IVF or IUI
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Added 16/12/2008:
Clinical pregnancy (ultrasound foetal heart[s]).
Secondary outcome measures
Added 16/12/2008:
Economic analysis: relative cost per live birth pregnancy.
Overall trial start date
01/07/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Infertility of 12 months or longer duration
2. Primary or secondary infertility
3. New patient or patient returning after an interval of longer than 1 year
4. Female age 18-42, male age 18-60 years
5. Detailed male and female partner clinical evaluation, investigation of semen quality and objective evidence of ovulation and tubal patency
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
1. Coital disorders, including infrequent or mistimed coitus (<1 per 3 days during mid cycle)
2. Tubal obstruction (one or both on sonohysterogram, laparoscopy or laparotomy) or known ligation
3. Male infertility requiring intracytoplasmic sperm injection (ICSI): average sperm concentration less than 2 million/ml, progressive motility less than 25%, or abnormal morphology greater than 95% in two or more semen tests performed within the previous 12 months in the Royal Women's Hospital andrology laboratory, sperm autoimmunity (Immunobead Test [IBT] IgG or IgA antibodies on >50% of motile sperm together with blocked sperm mucus penetration: < 3 cm at 1h in the capillary tube test), reduced sperm zona pellucida (ZP) binding (ratio <0.3) or disordered ZP-induced acrosome reaction (ZPIAR) (<16%) confirmed in 2 sperm ZP interaction tests, or less than 2 million motile sperm for IUI assessed by trial sperm preparation
4. Untreated ovulatory disorders (patients treated for 6 ovulatory cycles without a pregnancy can enter the trial)
5. Ovarian endometrioma (patients with treated or untreated mild endometriosis can enter the trial)
6. Miscellaneous (for example: a contraindication to multiple pregnancy)
7. Currently treated patients
Recruitment start date
01/07/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Australia
Trial participating centre
University of Melbourne Department of Obstetrics and Gynaecology
Carlton, Victoria
3053
Australia
Sponsor information
Organisation
The Royal Women's Hospital (Australia)
Sponsor details
132 Grattan Street
Carlton
Victoria
3053
Australia
+61 (0)3 9233 2759
arhtur.hui@rwh.org.au
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Added 16/12/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Serono Australia Ltd (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Melbourne IVF (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24579923
Publication citations
-
Results
Elzeiny H, Garrett C, Toledo M, Stern K, McBain J, Baker HW, A randomised controlled trial of intra-uterine insemination versus in vitro fertilisation in patients with idiopathic or mild male infertility., Aust N Z J Obstet Gynaecol, 2014, 54, 2, 156-161, doi: 10.1111/ajo.12168.