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Completed

NCT Number: NCT02339272

Study of Synapsis and Recombination in Male Meiosis and the Implications in Infertility

The aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA).

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Igenomix

Paterna, Valencia, 46980, Spain

About this study

During the first meiotic division in spermatogenesis there are two critical events. First, synapsis between homologous chromosomes and formation of the synaptonemal complex (SC), which regulates sister chromatid cohesion and provides the template for localization of recombination machinery proteins. Secondly, recombination between homologous chromosomes, which is essential for the correct segregation. Errors during these two processes may induce incorrect segregation of chromosomes and are a major cause of gamete aneuploidy. The aim of this study was to assess meiotic recombination in primary spermatocytes, synaptonemal complex length and the correlation with chromosomal abnormalities in testicular spermatozoa from infertile men with idiopathic non-obstructive azoospermia (NOA). Prospective cohort study to assess meiotic progression, total length of SC, frequency of recombination and sperm aneuploidy in samples obtained from testicular biopsies from NOA patients. The study group was compared with a control group from post-vasectomized (OA) patients. Immunocytogenetics with SCYP3, CREST and MLH1 antibodies for meiotic progression, SC length, and recombination. Fluorescence in situ Hybridization (FISH) for chromosomes 1, 4, 6, 13, 16, 18, 21, 22 in primary spermatocytes and chromosomes 13, 18, 21, X, Y on sperm. MicroMeasure 3.3 program was used for SC length.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NOA patients undergoing ICSI with testicular sperm
  • OA post-vasectomized patients undergoing ICSI with testicular sperm

Exclusion criteria

  • Abnormal Karyotype

Treatment and study plan

Non Interventional

Other

Primary outcomes

  1. Meiotic recombination

    Time frame: once

    Number of MLH1 foci in pachytene cells

Secondary outcomes

  1. Sperm aneuploidy

    Time frame: once

    Percentage of sperm with aneuploidies

Sponsors and collaborators

Lead sponsor

Igenomix

Industry

Collaborators

  • Instituto Universitario IVI

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Jan 15, 2015
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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