MenFERTIFORTNCT01895192
Sperm Morphology by High Magnification in Fertility Men
A study testing Assessment of sperm morphology (contrast microscopy). in people with Men and Fertility, run by University Hospital, Toulouse at 1 site in France.
Trial summary
A new concept for observing the fine morphology of spermatozoa at high magnification (x6000) with an inverted microscope, a numeric camera using differential interference contrast has been developed (1). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- What is being tested?
- Assessment of sperm morphology (contrast microscopy).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Feb 2013
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : between 18 and 45 years
- Sex : male
- Men with proven spontaneous fertility (the pregnancy started less than two years before inclusion)
- 2 to 5 days of sexual abstinence
- All subjects gave their informed consent to participate in the study
- The subjects must be affiliated to a social security scheme.
Who cannot join
- Personal history of infertility
- Personal history of chemotherapy
- History of recurrent miscarriage in the couple
- Andrological history since the last pregnancy: urogenital infection, testicular trauma, testicular torsion, varicocele, abdominopelvic surgery
- Fever within 3 months before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Sperm Morphology by High Magnification (x6000) With Interference Contrast Microscopy in Fertile Men.
A new concept for observing the fine morphology of spermatozoa at high magnification (x6000) with an inverted microscope, a numeric camera using differential interference contrast has been developed (1). This technique called Motile Sperm Organellar Morphology Examination allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3, 4). The application of Motile Sperm Organellar Morphology Examination may represent an improvement in the evaluation of semen quality, with some potential clinical repercussions at the diagnostic/prognostic level. First of all, the investigators need data on fertile men in order to define " normality " of sperm morphology at high magnification. The aim of this study is therefore to better characterize these vacuoles (number, surface, position) in a population of men fertile in order to establish normality criteria.
Read the detailed description
The population studied consisted in 50 men aged 18 to 45 years with proven spontaneous fertility. All subjects gave their informed consent to participate in the study. After questioning on full medical and andrological history, semen samples were collected by masturbation after 2 to 5 days of sexual abstinence and were processed for analysis after liquefaction for 20 min at 37°C. We carried out a sperm count, motility, vitality and conventional morphology analysis as well as a detailed morphometric analysis of the vacuoles at high magnification using an image analysis software. For the analysis at high magnification, fifty microliters of fresh sperm was washed in 2.5 ml of washing solution by centrifugation for 5 minutes at 400g. The pellet was resuspended in 100 µl of washing solution and the spermatozoa were fixed by addition of 100 µl Phosphate Buffer Saline-formaldehyde 3.7%. Two microliters of this suspension was placed in a glass-bottomed dish and examined by Nomarski interference contrast microscopy with a camera mounted on a microscope with an immersion objective lens x100. For each sample, sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Measurements using the software were carried out by a single operator. The Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded.
- Being tested
- Assessment of sperm morphology (contrast microscopy).
- Keywords
- sperm morphology, vacuoles, fertile, Motile Sperm Organellar Morphology Examination, high magnification, reference values
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sperm morphology (contrast microscopy).Other
Sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded. Relative vacuole area is the ratio of the area of all the vacuoles of a spermatozoon to the area of its head.
| Study group | Role | What they receive |
|---|---|---|
| Fertile men | Other | Assessment of sperm morphology by high magnification with interference contrast microscopy. Receives: Other: Assessment of sperm morphology (contrast microscopy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of vacuole and mean vacuolar area
For each patient, images of 100 spermatozoa was captured the day of the sperm collection
Measured: 1 day
Secondary outcomes (1)
Composite outcome measure: Vacuole localization, Semen volume, sperm count, motility, vitality, percentage of normal forms.
For each patient, the secondary outcome measures were collected the day of the inclusion.
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 posted10 Jul 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger LEANDRI, MD-PhD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895192
- Sponsor's protocol ID
- 11 175 03
- Other IDs
- HAO 2011
- Acronym
- FERTIFORT
- Status last verified
- Jul 2013
- First submitted
- 22 Jan 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sperm Morphology by High Magnification (x6000) With Interference Contrast Microscopy in Fertile Men.
- ClinicalTrials.gov ID
- NCT01895192
- Acronym / sponsor ID
- FERTIFORT / 11 175 03
- Keywords
- sperm morphology, vacuoles, fertile, Motile Sperm Organellar Morphology Examination, high magnification, reference values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jul 2013 (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.
A new concept for observing the fine morphology of spermatozoa at high magnification (x6000) with an inverted microscope, a numeric camera using differential interference contrast has been developed (1). This technique called Motile Sperm Organellar Morphology Examination allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3, 4). The application of Motile Sperm Organellar Morphology Examination may represent an improvement in the evaluation of semen quality, with some potential clinical repercussions at the diagnostic/prognostic level. First of all, the investigators need data on fertile men in order to define " normality " of sperm morphology at high magnification. The aim of this study is therefore to better characterize these vacuoles (number, surface, position) in a population of men fertile in order to establish normality criteria.
Detailed description
The population studied consisted in 50 men aged 18 to 45 years with proven spontaneous fertility. All subjects gave their informed consent to participate in the study. After questioning on full medical and andrological history, semen samples were collected by masturbation after 2 to 5 days of sexual abstinence and were processed for analysis after liquefaction for 20 min at 37°C. We carried out a sperm count, motility, vitality and conventional morphology analysis as well as a detailed morphometric analysis of the vacuoles at high magnification using an image analysis software. For the analysis at high magnification, fifty microliters of fresh sperm was washed in 2.5 ml of washing solution by centrifugation for 5 minutes at 400g. The pellet was resuspended in 100 µl of washing solution and the spermatozoa were fixed by addition of 100 µl Phosphate Buffer Saline-formaldehyde 3.7%. Two microliters of this suspension was placed in a glass-bottomed dish and examined by Nomarski interference contrast microscopy with a camera mounted on a microscope with an immersion objective lens x100. For each sample, sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Measurements using the software were carried out by a single operator. The Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fertile men | Other | Other: Assessment of sperm morphology (contrast microscopy).Assessment of sperm morphology by high magnification with interference contrast microscopy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age : between 18 and 45 years
- Sex : male
- Men with proven spontaneous fertility (the pregnancy started less than two years before inclusion)
- 2 to 5 days of sexual abstinence
- All subjects gave their informed consent to participate in the study
Key exclusion criteria (5 listed)
- Personal history of infertility
- Personal history of chemotherapy
- History of recurrent miscarriage in the couple
- Andrological history since the last pregnancy: urogenital infection, testicular trauma, testicular torsion, varicocele, abdominopelvic surgery
- Fever within 3 months before inclusion.
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 |
|---|---|---|
| Assessment of sperm morphology (contrast microscopy).Sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded. Relative vacuole area is the ratio of the area of all the vacuoles of a spermatozoon to the area of its head. | Other | Fertile men |
Primary outcome
Mean number of vacuole and mean vacuolar area
Time frame: 1 day
For each patient, images of 100 spermatozoa was captured the day of the sperm collection
1 secondary outcome
Composite outcome measure: Vacuole localization, Semen volume, sperm count, motility, vitality, percentage of normal forms.
Time frame: 1 day
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 10 Jul 2013.
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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.
Roger LEANDRI, MD-PhD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of sperm morphology (contrast microscopy). in people with Men and Fertility, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 5 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 10 Jul 2013. 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 France. 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?
Mean number of vacuole and mean vacuolar area (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2013.