Early versus late insemination relative to ovulation in subfertile couples: a trial-based cost-effectiveness study.
Completed
- Conditions
- Subfertilityunfulfilled childwish.10013356
- Registration Number
- NL-OMON40074
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 358
Inclusion Criteria
Couples with unexplained subfertility, mild male factor subfertility and cervical factor subfertility are eligible for IUI according to the present Dutch national guidelines, and they will be offered inclusion in this study.
Exclusion Criteria
In case of female age > 40 years old, female body mass index > 30 kg/m2, double-sided tubal pathology or severe male factor subfertility (< 1 million progressive motile sperm cells per sample in repeated semen analyses), the couple will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter/endpoint is the ongoing pregnancy rate per IUI-MOS<br /><br>treatment strategy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Ongoing pregnancy rate per cycle and per cause of subfertility, miscarriage<br /><br>rate, multiple pregnancy rate, live birth rate , adverse events,<br /><br>cost-effectiveness, cost-savings, budget impact resulting from a reduction of<br /><br>the need for additional IUI-MOS cycles and subsequent IVF-treatments, patient<br /><br>satisfaction and quality of life. </p><br>