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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose Bellver, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00447395
First received: March 13, 2007
Last updated: October 21, 2015
Last verified: October 2015
  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:


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

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)
Groups/Cohorts
GROUP 1
Recurrent miscarriage, <40 year-old-men, < 38 year-old-women, normal or mild affected sperm, normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy
GROUP 2
•Recurrent miscarriage, <40 year-old-men, < 38 year-old-women, oligozoospermia (1-5 mill/ml), normal parents karyotype, no thrombophilia, normal uterus, no endocrinopathy
GROUP 3
•Oligozoospermia (1-5 mill/ml), < 40 year-old-men, no recurrent miscarriages
GROUP 4
•Healthy young sperm donors

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, IVI VALENCIA
Investigators
Principal Investigator: Jose Bellver, MD IVI Valencia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose Bellver, Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT00447395     History of Changes
Other Study ID Numbers: VLC-JB-1106-307-4 
Study First Received: March 13, 2007
Last Updated: October 21, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications

ClinicalTrials.gov processed this record on December 06, 2016