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Clinical Trials/ISRCTN28780587
ISRCTN28780587
Completed
Not Applicable

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

The Royal Women's Hospital (Australia)0 sites600 target enrollmentMarch 17, 2004
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
The Royal Women's Hospital (Australia)
Enrollment
600
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 17, 2004
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
The Royal Women's Hospital (Australia)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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