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

NCT ID: NCT02339272

Last Updated: 2015-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Abnormal Spermatogenesis Azoospermia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NOA

Infertile males with non obstructive azoospermia

non interventional

Intervention Type OTHER

OA

Post-vasectomized patients with proven fertility before vasectomy

non interventional

Intervention Type OTHER

Interventions

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non interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Abnormal Karyotype
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Universitario IVI

OTHER

Sponsor Role collaborator

Igenomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Rubio, PhD

Role: PRINCIPAL_INVESTIGATOR

Lab Director

Locations

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Igenomix

Paterna, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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070-C-027-CR

Identifier Type: -

Identifier Source: org_study_id

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