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

Azoospermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339272
• Other study ID #: 070-C-027-CR
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: January 14, 2015
• Start date: January 2008
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Igenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• NOA patients undergoing ICSI with testicular sperm

• OA post-vasectomized patients undergoing ICSI with testicular sperm

Exclusion Criteria:

• Abnormal Karyotype

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abnormal Spermatogenesis
• Azoospermia
• Infertility

Intervention

Other:
• non interventional

Locations

Country	Name	City	State
Spain	Igenomix	Paterna	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Igenomix	Instituto Universitario IVI

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meiotic recombination	Number of MLH1 foci in pachytene cells	once	No
Secondary	Sperm aneuploidy	Percentage of sperm with aneuploidies	once	No