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

Recurrent Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447395
• Other study ID #: VLC-JB-1106-307-4
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: October 21, 2015
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: October 2015
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Miscarriage

Locations

Country	Name	City	State
Spain	Ivi Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain,