Male InfertilityNCT02062229
Oxidative Stress and Lipidomics in Male Infertility
An observational study of Male Infertility, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Infertility is a common problem, affecting perhaps one couple in six, the majority of whom now seek medical care. It is becoming a social challenge because it is responsible for personal and interpersonal discomfort and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Jun 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Subjects referring to an infertility center
Who may be able to join
- clinically healthy subjects and clinical healthy subjects with infertility
Who cannot join
- subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer
- subjects taking medicines and/or supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
Infertility is a common problem, affecting perhaps one couple in six, the majority of whom now seek medical care. It is becoming a social challenge because it is responsible for personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by the conventional assessment of the semen profile - constructed according to recognized guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers are available.
We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid biomarker useful for the diagnosis of male infertility.
Read the detailed description
Subjects referring to an outpatient infertility laboratory will be enrolled in the study. A complete clinical record is collected as well as a sperm and a fasting blood sample. Patients are stratified according to current guidelines focusing on sperm and anatomical characteristics. Sperm characteristics will be studied on fresh samples immediately after collection; blood samples will be centrifuged and plasma stored at -80°C until analysis that include routine glucose and lipid profile by commercial kits. Vitamin E (alpha- and gamma-tocopherol), oxysterols profiling, and fatty acids profiling is analyzed by state of the art gas chromatography-mass spectrometry (GC/MS) using isotope dilution methods.
- Conditions
- Male Infertility
- Keywords
- oxidative stress, oxysterols, fatty acids, seminal fluid
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Halthy controls | Subjects not affected by any disease and with normal seminal fluid characteristics | |
| Oligospermia | Infertile subjects with oligospermia | |
| Varicocele | Infertile subjects with varicocele | |
| Asthenospermia | Infertile subjects with asthenospermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxysterol profiling in seminal fluid
Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
Measured: 1 day
Secondary outcomes (1)
Fatty acids lipidomics
Profiling of fatty acids in seminal fluid will be assessed by GC/MS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionJun 2016 (estimated)
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.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Civic Hospital, Italy
- Responsible party
- Principal investigator, Luigi Iuliano, University of Roma La Sapienza
- Investigators
- Rocco Rago, M.D., Principal investigator, Civic HospitalLuigi Iuliano, M.D., Study director, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062229
- Sponsor's protocol ID
- IULIANO_Rago
- Status last verified
- Dec 2015
- First submitted
- 7 Feb 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zerbinati C, Caponecchia L, Rago R, Leoncini E, Bottaccioli AG, Ciacciarelli M, Pacelli A, Salacone P, Sebastianelli A, Pastore A, Palleschi G, Boccia S, Carbone A, Iuliano L. Fatty acids profiling reveals potential candidate markers of semen quality. Andrology. 2016 Nov;4(6):1094-1101. doi: 10.1111/andr.12236. Epub 2016 Sep 27.
PubMed 27673576
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
- ClinicalTrials.gov ID
- NCT02062229
- Acronym / sponsor ID
- IULIANO_Rago
- Conditions
- Male Infertility
- Keywords
- oxidative stress, oxysterols, fatty acids, seminal fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Civic Hospital, Italy
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 Feb 2014 (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.
Infertility is a common problem, affecting perhaps one couple in six, the majority of whom now seek medical care. It is becoming a social challenge because it is responsible for personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by the conventional assessment of the semen profile - constructed according to recognized guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers are available.
We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid biomarker useful for the diagnosis of male infertility.
Detailed description
Subjects referring to an outpatient infertility laboratory will be enrolled in the study. A complete clinical record is collected as well as a sperm and a fasting blood sample. Patients are stratified according to current guidelines focusing on sperm and anatomical characteristics. Sperm characteristics will be studied on fresh samples immediately after collection; blood samples will be centrifuged and plasma stored at -80°C until analysis that include routine glucose and lipid profile by commercial kits. Vitamin E (alpha- and gamma-tocopherol), oxysterols profiling, and fatty acids profiling is analyzed by state of the art gas chromatography-mass spectrometry (GC/MS) using isotope dilution methods.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Halthy controls | – | –Subjects not affected by any disease and with normal seminal fluid characteristics |
| Oligospermia | – | –Infertile subjects with oligospermia |
| Varicocele | – | –Infertile subjects with varicocele |
| Asthenospermia | – | –Infertile subjects with asthenospermia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects referring to an infertility center
Key inclusion criteria (1 listed)
- clinically healthy subjects and clinical healthy subjects with infertility
Key exclusion criteria (2 listed)
- subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer
- subjects taking medicines and/or supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxysterol profiling in seminal fluid
Time frame: 1 day
Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
1 secondary outcome
Fatty acids lipidomics
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Derived from this study: PubMed 27673576Zerbinati C, Caponecchia L, Rago R, Leoncini E, Bottaccioli AG, Ciacciarelli M, Pacelli A, Salacone P, Sebastianelli A, Pastore A, Palleschi G, Boccia S, Carbone A, Iuliano L. Fatty acids profiling reveals potential candidate markers of semen quality. Andrology. 2016 Nov;4(6):1094-1101. doi: 10.1111/andr.12236. Epub 2016 Sep 27.
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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.
Rocco Rago, M.D. principal investigator
Civic Hospital
Luigi Iuliano, M.D. study director
University of Roma La Sapienza
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 University of Roma La Sapienza at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Dec 2015. 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 Italy. 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?
Results are not available in the source record.
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?
Oxysterol profiling in seminal fluid (time frame: 1 day). 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 NCT02062229, 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 11 Dec 2015.