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

Completed

• Conditions: Idiopathic or mild male infertility; Pregnancy and Childbirth

• Registration Number: ISRCTN28780587
• Lead Sponsor: The Royal Women's Hospital (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified