Status:

RECRUITING

The Efficiency of a New Sperm-Wash Device for Intrauterine Insemination in Couples With Infertility

Lead Sponsor:

Chung Shan Medical University

Conditions:

Infertility

Male Infertility

Eligibility:

MALE

25-50 years

Phase:

NA

Brief Summary

This study evaluates the effectiveness of a novel sperm-wash device designed to improve outcomes in intrauterine insemination (IUI) for couples with infertility. Traditional sperm preparation methods,...

Detailed Description

This is a prospective, randomized, open-label, parallel-controlled clinical trial conducted at Chung Shan Medical University Hospital. The study aims to evaluate the clinical efficacy and safety of a ...

Eligibility Criteria

Inclusion

  • Males aged between 25 to 50 years.
  • Part of a couple diagnosed with infertility.
  • Undergoing intrauterine insemination (IUI) treatment.
  • Sperm concentration \>15 million/mL, progressive motility \>32%, and total motile sperm count \>40 million after wash.
  • Willingness of both partners to participate and provide informed consent.

Exclusion

  • Known female infertility factors requiring assisted reproductive technologies beyond IUI.
  • Severe male factor infertility (e.g., oligoasthenoteratozoospermia).
  • Use of donor sperm or oocyte.
  • Chronic illness or medications affecting sperm quality.
  • Prior participation in another clinical trial within the past 3 months.

Key Trial Info

Start Date :

April 24 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06956287

Start Date

April 24 2025

End Date

December 31 2026

Last Update

May 8 2025

Active Locations (1)

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1

Chung Shan Medical University Hospital

Taichung, Taichung City, Taiwan, 40201