A study of the timing of intra-uterine insemination relative to ovulation.
Completed
- Conditions
- Subfertility.Subfertiliteit / verminderde vruchtbaarheid.
- Registration Number
- NL-OMON23163
- Lead Sponsor
- Maastricht University Medical Center +
- Brief Summary
/A
- 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 who are eligible for IUI (estimated spontaneous pregnancy chance of <30% in the coming year, according to the prognostic model of Hunault) can be included. Only couples who are about to start IUI treatment, are eligible for this study.
Exclusion Criteria
In case of female age > 42 years old, female BMI > 35 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 is excluded. Couples who have already undergone at least one IUI-MOS cycle, are not eligible for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameter/endpoint is ongoing pregnancy rate, as defined as a pregnancy with fetal cardiac activity at ultrasound at 12 weeks of gestation, per IUI treatment strategy.
- Secondary Outcome Measures
Name Time Method The secondary study parameters/endpoints are (ongoing) pregnancy rate per cycle, ongoing pregnancy rate per cause of subfertility, miscarriage rate, multiple pregnancy rate, live birth rate and adverse events. Other study parameters/endpoints are the cost-effectiveness of both strategies, potential cost-savings in view of a reduction of the need for additional IUI cycles and IVF treatment and patient satisfaction and quality of life.