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

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

September 17, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00447395 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Prospective

Condition ^ICMJE

Recurrent Miscarriage

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00447395

Responsible Party

Study ID Numbers ^ICMJE

VLC-JB-1106-307-4

Study Sponsor ^ICMJE

Instituto Valenciano de Infertilidad, Spain

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jose Bellver, MD

IVI Valencia

Information Provided By

Instituto Valenciano de Infertilidad, Spain

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP