Intrauterine insemination for unexplained or mild male subfertility

Completed

• Conditions: 10013356; unexplained subfertility and mild male subfertility

• Registration Number: NL-OMON50720
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1091

Inclusion Criteria

- At least 12 month unprotected regular intercourse or self insemination
without conception
- Regular ovulatory cycle
- At least one sided tubal patency, established according to local protocol
- Total motile sperm count (TMSC or VCM) above 3 million.
- An unfavourable prognosis for natural conception, defined as:
women of 18 years until 38 years with a prognosis < 30% (model of Hunault) or;
women of 38 years until 42 years or;
women of 18 years until 38 years with an initial favourable prognosis (>30 %
Hunault model) and returning after 6 months expectant management without
conception.
- Obtained written informed consent.

Exclusion Criteria

- ART in the current treatment episode
- IUI-OH with sperm bank donation
- Couples with a medical contra indication for pregnancy
- Couples with sexual problems interfering with the occurrence of a natural
conception pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ongoing pregnancy, conceived within a time horizon of 6 months after<br /><br>randomisation leading to live birth. Live Birth is defined as the birth of a<br /><br>baby at 24 or more weeks gestation.</p><br>