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

This study has been completed.

First Received on March 13, 2007. Last Updated on September 17, 2009 History of Changes

Sponsor:	Instituto Valenciano de Infertilidad, Spain
Information provided by:	Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:	NCT00447395

Purpose

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.

Condition
Recurrent Miscarriage

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Estimated Enrollment:	90
Study Start Date:	February 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Couples with recurrent miscarriages

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447395

Locations

Spain
Ivi Valencia
Valencia, Spain, 46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, Spain

Investigators

Principal Investigator:

Jose Bellver, MD

IVI Valencia

More Information

No publications provided by Instituto Valenciano de Infertilidad, Spain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bellver J, Meseguer M, Muriel L, García-Herrero S, Barreto MA, Garda AL, Remohí J, Pellicer A, Garrido N. Y chromosome microdeletions, sperm DNA fragmentation and sperm oxidative stress as causes of recurrent spontaneous abortion of unknown etiology. Hum Reprod. 2010 Jul;25(7):1713-21. Epub 2010 May 24.

ClinicalTrials.gov Identifier:	NCT00447395 History of Changes
Other Study ID Numbers:	VLC-JB-1106-307-4
Study First Received:	March 13, 2007
Last Updated:	September 17, 2009
Health Authority:	Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:

Congenital Abnormalities
Abortion, Spontaneous
Abortion, Missed

Abortion, Threatened
Abortion, Habitual
Pregnancy Complications

ClinicalTrials.gov processed this record on February 12, 2012