Condition category
Pregnancy and Childbirth
Date applied
11/02/2004
Date assigned
17/03/2004
Last edited
19/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24579923

Publication citations

  1. 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.

Additional files

Editorial Notes