Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.

Completed

• Conditions: Recurrent Miscarriage

• Registration Number: NCT00447395
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary

In recurrent miscarriage, the male factor has been poorly evaluated. In fact, in the vast majority of clinical protocols of recurrent miscarriage, the sperm is not considered or assessed. Recently, some studies have suggested the presence of genetic and metabolic sperm anomalies in couples suffering from repeated miscarriages. Specifically, DNA fragmentation and altered oxidative stress in the sperm and Y microdeletions from blood samples have been related to an increased risk of miscarriage.The aim of the present study is to compare these three parameters in: couples with recurrent miscarriage; oligozoospermic men with or without recurrent miscarriages; and healthy sperm donors, in order to determine their actual impact on this reproductive problem.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-14
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

4 groups

• Recurrent miscarriage, <40 year-old-men, < 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy
• The same criteria than in group A, but oligozoospermia (1-5 mill/ml)
• Oligozoospermia (1-5 mill/ml), < 40 year-old-men, no recurrent miscarriages
• Healthy young sperm donors

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Ivi Valencia; 🇪🇸 Valencia, Spain