A controlled trial of ovulation stimulation with intrauterine insemination (IUI) versus in vitro fertilisation (IVF)

ISRCTN	ISRCTN28780587
DOI	https://doi.org/10.1186/ISRCTN28780587
Secondary identifying numbers	03/07; ACTRN12605000027617

Submission date: 11/02/2004
Registration date: 17/03/2004
Last edited: 19/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gordon Baker
Scientific

University of Melbourne Department of Obstetrics and Gynaecology
Royal Women's Hospital
132 Grattan Street
Carlton, Victoria
3053
Australia

Phone	+61 (0)3 93442130
Email	g.baker@unimelb.edu.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Royal Women's Hospital Research and Ethics Committee, ref: 03/27
Health condition(s) or problem(s) studied	Idiopathic or mild male infertility
Intervention	Standard IVF, or low dose follicle stimulating hormone (FSH) with IVF or IUI
Intervention type	Other
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 study start date	01/07/2004
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Female
Target number of participants	600
Key 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
Key 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
Date of first enrolment	01/07/2004
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Australia

Study participating centre

University of Melbourne Department of Obstetrics and Gynaecology

Carlton, Victoria
3053
Australia

Sponsor information

The Royal Women's Hospital (Australia)
Hospital/treatment centre

132 Grattan Street
Carlton, Victoria
3053
Australia

Phone	+61 (0)3 9233 2759
Email	arhtur.hui@rwh.org.au
"ROR"	https://ror.org/03grnna41

Funders

Funder type

Industry

Added 16/12/2008:

No information available

Serono Australia Ltd (Australia)

No information available

Melbourne IVF (Australia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014		Yes	No