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

Completed

• Conditions: Azoospermia; Abnormal Spermatogenesis
• Interventions: Other: non interventional

• Registration Number: NCT02339272
• Lead Sponsor: Igenomix

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-15
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Abnormal Karyotype

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NOA	non interventional	Infertile males with non obstructive azoospermia
OA	non interventional	Post-vasectomized patients with proven fertility before vasectomy

Primary Outcome Measures

Name	Time	Method
Meiotic recombination	once	Number of MLH1 foci in pachytene cells

Secondary Outcome Measures

Name	Time	Method
Sperm aneuploidy	once	Percentage of sperm with aneuploidies

Trial Locations

Locations (1)

Igenomix; 🇪🇸 Paterna, Valencia, Spain