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

Completed

• Conditions: reproductive technology; unexplained subfertility; 10013356

• Registration Number: NL-OMON41321
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 732

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ongoing pregnancy rate </p><br>

Secondary Outcome Measures

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