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

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Conditions

Recurrent Miscarriage

Study type

Observational

Funder types

Other

Identifiers

NCT00447395
VLC-JB-1106-307-4

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

90 participants in 4 patient groups

GROUP 1
Description:
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
Description:
•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
Description:
•Oligozoospermia (1-5 mill/ml), \< 40 year-old-men, no recurrent miscarriages
GROUP 4
Description:
•Healthy young sperm donors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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