Genetic Abnormalities and Oxidative Stress in Sperm as Cause of Recurrent Miscarriage.
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Feb 2007
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 13, 2007
CompletedFirst Posted
Study publicly available on registry
March 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedOctober 22, 2015
October 1, 2015
2 years
March 13, 2007
October 21, 2015
Conditions
Study Arms (4)
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 Criteria
Couples with recurrent miscarriages
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ivi Valencia
Valencia, Valencia, 46015, Spain
Related Publications (1)
Bellver J, Meseguer M, Muriel L, Garcia-Herrero S, Barreto MA, Garda AL, Remohi 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. doi: 10.1093/humrep/deq098. Epub 2010 May 24.
PMID: 20501469DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Bellver, MD
IVI Valencia
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gynecologist IVI Valencia
Study Record Dates
First Submitted
March 13, 2007
First Posted
March 14, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
October 22, 2015
Record last verified: 2015-10