A controlled trial of ovulation stimulation with intrauterine insemination (IUI) versus in vitro fertilisation (IVF)
| ISRCTN | ISRCTN28780587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28780587 |
| Protocol serial number | 03/07; ACTRN12605000027617 |
| Sponsor | The Royal Women's Hospital (Australia) |
| Funders | Added 16/12/2008:, Serono Australia Ltd (Australia), Melbourne IVF (Australia) |
- 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
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 |
|---|---|
| g.baker@unimelb.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Added 16/12/2008: |
| Key secondary outcome measure(s) |
Added 16/12/2008: |
| 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 sample size at registration | 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
3053
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
