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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Recurrent Miscarriage

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

GROUP 3

•Oligozoospermia (1-5 mill/ml), \< 40 year-old-men, no recurrent miscarriages

No interventions assigned to this group

GROUP 4

•Healthy young sperm donors

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes