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Super ovulation in Intra uterine insemination: FSH or Clomifene citrate? The Super Trial.

Super ovulation in Intra uterine insemination: FSH or Clomifene citrate? The Super Trial. - The Super trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41321
Enrollment
732
Registered
2013-04-16
Start date
2013-06-05
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

reproductive technology unexplained subfertility

Interventions

A maximum of 4 cycles of IUI with ovarian stimulation with either FSH or CC in a time horizon of 6 months.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Couples diagnosed with unexplained subfertility or mild male factor;Unexplained subfertility is defined as: 12 month unprotected regular intercourse male partner had normal or mild impairment of semen quality with total motile sperm count above 10 millon female partner has a regular menstrual cycle, at least one sided tubal patency Poor prognosis for natural conception according to model of Hunault (dutch guidelines) in order to justify start of treatment with IUI

Exclusion criteria

Exclusion criteria: - double sided tubal pathology - impaired semen quality - women with irregular cycle - age below 18 and above 42

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate

Secondary

MeasureTime frame
1. Number of cycles with monofollicular growth 2. Number of cycles with multiple follicle growth 3. Number of cancelled cycles due to the occurrence of >3 follicles >15 mm 4. Difference in severity of known adverse effects 5. Time to ongoing pregnancy rate 6. Clinical pregnancy 7. Miscarriage rate 8. Live birth rate 9. Multiple pregnancies 10. Patients preference by DCE 11. Direct and indirect costs

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)