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CompletedNCT00447395Updated Oct 22, 2015

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

An observational study in Recurrent Miscarriage, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-22.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

03

In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's enrollment of 90 is below the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Couples with recurrent miscarriages

Eligibility 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
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Study design

Time perspective
Prospective
Enrollment
90 participants (actual)

Groups and 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

06

Study locations

1 site
  • Ivi Valencia
    Valencia, 46015, Spain
07

References and documents

Publications

  • 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. PubMed 20501469 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00447395
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Jose Bellver (Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA) — Principal investigator
First posted
Mar 14, 2007
Start date
Feb 2007
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Oct 22, 2015

Study contacts

Jose Bellver, MD
principal investigator · IVI Valencia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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