NCT02339272

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

6.9 years

First QC Date

January 12, 2015

Last Update Submit

January 14, 2015

Conditions

Abnormal SpermatogenesisAzoospermia

Keywords

meiosissynapsisrecombinationsperm aneuploidy

Outcome Measures

Primary Outcomes (1)

  • Meiotic recombination

    Number of MLH1 foci in pachytene cells

    once

Secondary Outcomes (1)

  • Sperm aneuploidy

    once

Study Arms (2)

NOA

Infertile males with non obstructive azoospermia

Other: non interventional

OA

Post-vasectomized patients with proven fertility before vasectomy

Other: non interventional

Interventions

non interventionalOTHER
NOAOA

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Testicular biopsies from NOA patients and a control group from post-vasectomized (OA) patients.

You may qualify if:

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

You may not qualify if:

  • Abnormal Karyotype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Igenomix

Paterna, Valencia, 46980, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed slides with paraformaldehide, and metanol-acetic acid

MeSH Terms

Conditions

Azoospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Carmen Rubio, PhD

    Lab Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 15, 2015

Study Start

January 1, 2008

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

ES(1)