NCT00481403

Brief Summary

Sperm analysis following World Health Organization guidelines is unable to explain the molecular causes of male infertility when basic sperm parameters are within a normal range and women do not present gynaecological pathology. Subsequently, there is a need for accurate diagnostic tools in this sense and microarray technology applied to sperm analysis emerges as a promising field

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

10.6 years

First QC Date

May 31, 2007

Last Update Submit

March 31, 2022

Conditions

Keywords

Sperm, male fertility, microarrays

Outcome Measures

Primary Outcomes (1)

  • Sperm mRNAs expression profile in samples achieving pregnancy vs those who failed in different assisted reproduction techniques

    10 months

Interventions

Microarray analysis

MicroarrayBEHAVIORAL

Microarray

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile male undergoing assisted reproduction technique without abnormal sperm parameters described by the OMS. Female partners are under 37 years old, IBM lower than 30 kg/m2 and do not present any obvious infertility problem as fallopian tubal obstruction, endometriosis, ovarian failure or polycystic ovarian syndrome.

You may qualify if:

  • Fertile (controls) or infertile males, with sperm parameters above the WHO criteria values

You may not qualify if:

  • Well established infertility causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Universitario Ivi

Valencia, 46015, Spain

Location

Related Publications (1)

  • 1. Garrido N, Meseguer M, Alvarez J, Simon C, Pellicer A, Remohi J. Relationship among standard semen parameters, glutathione peroxidase/glutathione reductase activity, and mRNA expression and reduced glutathione content in ejaculated spermatozoa from fertile and infertile men. Fertil Steril. 2004 Oct;82 Suppl 3:1059-66. 2. Krawetz SA. Paternal contribution: New insights and future challenges. Nat Rev Genet. 2005;6:633-42. 3. Kramer JA, Krawetz SA. RNA in spermatozoa: Implications for the alternative haploid genome. Mol Hum Reprod. 1997;3:473-8. 4. Wykes SM, Visscher DW, Krawetz SA. Haploid transcripts persist in mature human spermatozoa. Mol Hum Reprod. 1997; 3:15-9.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

After sperm washing, sperm pellet was suspended in trizol and immediately frozen by direct immersion in liquid nitrogen and stored in a nitrogen tank until mRNA extraction.

MeSH Terms

Conditions

Infertility, Male

Interventions

Microarray AnalysisGene Expression Profiling

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesGenetic Techniques

Study Officials

  • Nicolas Garrido, PhD

    Instituto Universitario IVI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Andrology IVI Valencia

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 1, 2007

Study Start

May 1, 2006

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 1, 2022

Record last verified: 2022-03

Locations