Semen QualityNCT02667080
Sperm Quality in Consecutive Sperm Samples After 4-7 Days and 2 Hours of Sexual Abstinence
A study testing 2-7 days of Sexual abstinence and 2 hours of sexual abstinence in people with Semen Quality, run by Aalborg University at 1 site in Denmark.
Trial summary
The main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples… 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
- Semen Quality
- What is being tested?
- 2-7 days of Sexual abstinence and 2 hours of sexual abstinence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to 1 Nov 2016
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male age between 18 and 50
- able to understand and read Danish
Who cannot join
- complete azospermia
- significant psychological illness
- significant cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital, Dronninglund Fertility Clinic
Dronninglund, 9330
About this study
Official title: Parameters of Sperm Quality in Consecutive Sperm Samples From Males Partners of Couples Seeking Treatment for Infertility
The main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples referring for ART treatment.
- Conditions
- Semen Quality
- Being tested
- 2-7 days of Sexual abstinence, 2 hours of sexual abstinence
- Keywords
- Semen quality, Sexual Abstinence, sperm motility, DNA fragmentation
- Medical subject headings
- Sexual Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-7 days of Sexual abstinenceOther
2-7 days of Sexual abstinence
2 hours of sexual abstinenceOther
2 hours of sexual abstinence
| Study group | Role | What they receive |
|---|---|---|
| Ejaculate 1 | Active comparator | Semen sample after 2-7 days of sexual abstinence Receives: Other: 2-7 days of Sexual abstinence |
| Ejaculate 2 | Active comparator | Semen sample after 2 hours of sexual abstinence Receives: Other: 2 hours of sexual abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine semen quality assessment
Routine sperm quality check including Morphology, Motility and DNA fragmentation index using both the conventional manual method and computer assisted sperm analysis (CASA) systems.
Measured: After liquefaction (30-35 minutes after ejaculation)
Secondary outcomes (1)
Outcome of ART treatments
assessing and correlating the sperm quality with the results of the ART procedures
Measured: up to one year after the sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startApr 2014
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Semen QualityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Hiva Alipour, Aalborg University
- Investigators
- Ole Bjarane M.D., Ph.D., M.D., Ph.D., Study director, Aalborg University Hospital, Gynecology DepartmentHiva Alipour, D.V.M., Principal investigator, Aalborg University, Faculty of Medicine, Department of Health Science and TechnologyFereshteh Dardmeh, D.V.M., Study chair, Aalborg University, Faculty of Medicine, Department of Health Science and TechnologyGerhard Van DerHorst, Ph.D., Study chair, University of the Western Cape, Capetown, South AfricaChristina Hnida, Ph.D., Study chair, Aalborg University Hospital, Gynecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667080
- Sponsor's protocol ID
- N-20140023
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters of Sperm Quality in Consecutive Sperm Samples From Males Partners of Couples Seeking Treatment for Infertility
- ClinicalTrials.gov ID
- NCT02667080
- Acronym / sponsor ID
- N-20140023
- Conditions
- Semen Quality
- Keywords
- Semen quality, Sexual Abstinence, sperm motility, DNA fragmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- Apr 2014
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 28 Jan 2016 (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.
The main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples referring for ART treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ejaculate 1 | Active comparator | Other: 2-7 days of Sexual abstinenceSemen sample after 2-7 days of sexual abstinence |
| Ejaculate 2 | Active comparator | Other: 2 hours of sexual abstinenceSemen sample after 2 hours of sexual abstinence |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male age between 18 and 50
- able to understand and read Danish
Key exclusion criteria (3 listed)
- complete azospermia
- significant psychological illness
- significant cardiovascular disease
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 |
|---|---|---|
| 2-7 days of Sexual abstinence2-7 days of Sexual abstinence | Other | Ejaculate 1 |
| 2 hours of sexual abstinence2 hours of sexual abstinence | Other | Ejaculate 2 |
Primary outcome
Routine semen quality assessment
Time frame: After liquefaction (30-35 minutes after ejaculation)
Routine sperm quality check including Morphology, Motility and DNA fragmentation index using both the conventional manual method and computer assisted sperm analysis (CASA) systems.
1 secondary outcome
Outcome of ART treatments
Time frame: up to one year after the sampling
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 24 Jan 2017.
- Individual participant dataSharing planned: No
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Semen Quality
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.
Ole Bjarane M.D., Ph.D., M.D., Ph.D. study director
Aalborg University Hospital, Gynecology Department
Hiva Alipour, D.V.M. principal investigator
Aalborg University, Faculty of Medicine, Department of Health Science and Technology
Fereshteh Dardmeh, D.V.M. study chair
Aalborg University, Faculty of Medicine, Department of Health Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-7 days of Sexual abstinence and 2 hours of sexual abstinence in people with Semen Quality, run by Aalborg University at 1 site in Denmark.
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 2 inclusion and 3 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 24 Jan 2017. 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 Denmark. 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?
Routine semen quality assessment (time frame: After liquefaction (30-35 minutes after ejaculation)). 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 24 Jan 2017; AzTrials last refreshed its copy on 29 Oct 2026.