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

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ClinicalTrials.gov Identifier: NCT00447395
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Jose Bellver, 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.

Condition or disease
Recurrent Miscarriage

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Study Type : Observational
Actual Enrollment : 90 participants
Time Perspective: Prospective
Official Title: Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.
Study Start Date : February 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Group/Cohort
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




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447395


Locations
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Spain
Ivi Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
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Principal Investigator: Jose Bellver, MD IVI Valencia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

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