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Early versus late insemination relative to ovulation in subfertile couples: a trial-based cost-effectiveness study.

Early versus late insemination relative to ovulation in subfertile couples: a trial-based cost-effectiveness study. - Early versus late insemination relative to ovulation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40074
Enrollment
358
Registered
2012-01-11
Start date
2013-02-13
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility unfulfilled childwish.

Interventions

In group one (*late IUI*), IUI will be performed 32-36 hours after triggering of ovulation by hCG, which is administered when the largest follicle has reached a diameter of 16-18 mm. In group two ("

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

MeasureTime frame
The main study parameter/endpoint is the ongoing pregnancy rate per IUI-MOS treatment strategy.

Secondary

MeasureTime frame
Ongoing pregnancy rate per cycle and per cause of subfertility, miscarriage rate, multiple pregnancy rate, live birth rate , adverse events, cost-effectiveness, cost-savings, budget impact resulting from a reduction of the need for additional IUI-MOS cycles and subsequent IVF-treatments, patient satisfaction and quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)