Male InfertilityNCT00481403
Study of Sperm Molecular Factors Implicated in Male Fertility
An observational study of Male Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Microarray analysis and Microarray
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- May 2006to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Fertile (controls) or infertile males, with sperm parameters above the WHO criteria values
Who cannot join
- Well established infertility causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microarray Analysis in Sperm From Fertile and Infertile Males Without Basic Sperm Analysis Abnormalities
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
Read the detailed description
Sperm analysis based in sperm count and motility has been employed for the diagnosis of male fertility for several decades. It is an easy, inexpensive and useful tool to determine the fertile status of a male but there is still a significant number of infertile males with normal sperm features, as determined by the basic sperm analysis, while they remain unable to reach a full-term pregnancy (1). This fact clearly indicates the need to develop new male infertility tests and accurately diagnose the sperm samples from these individuals.
Recent investigations about sperm mRNA contents have described the relevance of the sperm mRNA stock in fertilization and early embryo development in several species. (2) Although sperm is a quiescent cell from the translational point of view, several functional mRNAs that will be delivered into the oocyte after fertilization, that were synthesized in an earlier phase of the spermatogenesis process can be found (3, 4).
The fertile male transcriptome (stock of mRNAs within the sperm of a male able to have progeny) has been already described (5, 6), confirming the expression of thousands of sequence tags with different intensity of expression.
Moreover, several investigations have demonstrated that a differential expression of some key mRNAs is found in infertile males in comparison with fertile males (1, 7).
Nevertheless, there is no information available neither about the characteristics of the stock sperm mRNAs on infertile males or the differences between fertile and infertile men, although several authors have hypothesized that sperm microarray analysis will be the future in the male infertility diagnosis (2, 8-11).
Microarray technology provides information about a wide range of mRNAs expression within a single experiment, permitting to analyze complete sperm expression profiles (SEP) in cells or tissues. Bioinformatics can help in the organization of such amount of results by following logical processes of gene expression grouping, and analyzing statistically these findings.
Our aim with this work was to compare the SEP in spermatozoa obtained from males with idiopathic infertility versus those from sperm donors of proven fertility by employing microarray technology followed by a functional analysis, in order to determine the genes, sequences and biological processes involved in the sperm physiology that are different in infertile vs. fertile males.
- Conditions
- Male Infertility
- Being tested
- Microarray analysis, Microarray
- Keywords
- Sperm, male fertility, microarrays
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microarray analysisBehavioural
Microarray analysis
MicroarrayBehavioural
Microarray
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm mRNAs expression profile in samples achieving pregnancy vs those who failed in different assisted reproduction techniques
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Garrido, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Nicolas Garrido, PhD, Principal investigator, Instituto Universitario IVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481403
- Sponsor's protocol ID
- VLC-NG-0506-(1003-C-068-JH)
- Status last verified
- Mar 2022
- First submitted
- 31 May 2007
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/j.fertnstert.2004.04.033.
PubMed 15474074
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microarray Analysis in Sperm From Fertile and Infertile Males Without Basic Sperm Analysis Abnormalities
- ClinicalTrials.gov ID
- NCT00481403
- Acronym / sponsor ID
- VLC-NG-0506-(1003-C-068-JH)
- Conditions
- Male Infertility
- Keywords
- Sperm, male fertility, microarrays
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Sperm analysis based in sperm count and motility has been employed for the diagnosis of male fertility for several decades. It is an easy, inexpensive and useful tool to determine the fertile status of a male but there is still a significant number of infertile males with normal sperm features, as determined by the basic sperm analysis, while they remain unable to reach a full-term pregnancy (1). This fact clearly indicates the need to develop new male infertility tests and accurately diagnose the sperm samples from these individuals.
Recent investigations about sperm mRNA contents have described the relevance of the sperm mRNA stock in fertilization and early embryo development in several species. (2) Although sperm is a quiescent cell from the translational point of view, several functional mRNAs that will be delivered into the oocyte after fertilization, that were synthesized in an earlier phase of the spermatogenesis process can be found (3, 4).
The fertile male transcriptome (stock of mRNAs within the sperm of a male able to have progeny) has been already described (5, 6), confirming the expression of thousands of sequence tags with different intensity of expression.
Moreover, several investigations have demonstrated that a differential expression of some key mRNAs is found in infertile males in comparison with fertile males (1, 7).
Nevertheless, there is no information available neither about the characteristics of the stock sperm mRNAs on infertile males or the differences between fertile and infertile men, although several authors have hypothesized that sperm microarray analysis will be the future in the male infertility diagnosis (2, 8-11).
Microarray technology provides information about a wide range of mRNAs expression within a single experiment, permitting to analyze complete sperm expression profiles (SEP) in cells or tissues. Bioinformatics can help in the organization of such amount of results by following logical processes of gene expression grouping, and analyzing statistically these findings.
Our aim with this work was to compare the SEP in spermatozoa obtained from males with idiopathic infertility versus those from sperm donors of proven fertility by employing microarray technology followed by a functional analysis, in order to determine the genes, sequences and biological processes involved in the sperm physiology that are different in infertile vs. fertile males.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Fertile (controls) or infertile males, with sperm parameters above the WHO criteria values
Key exclusion criteria (1 listed)
- Well established infertility causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microarray analysisMicroarray analysis | Behavioural | – |
| MicroarrayMicroarray | Behavioural | – |
Primary outcome
Sperm mRNAs expression profile in samples achieving pregnancy vs those who failed in different assisted reproduction techniques
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 15474074Garrido 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. doi: 10.1016/j.fertnstert.2004.04.033.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Garrido, PhD principal investigator
Instituto Universitario IVI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm mRNAs expression profile in samples achieving pregnancy vs those who failed in different assisted reproduction techniques (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.