Infertility, MaleSemiFluidNCT02932865
Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
An observational study of Infertility, Male, run by Turku University Hospital at 1 site in Finland.
Trial summary
Men are recruited to collect seminal plasma samples and serum samples from men with azoospermia, men receiving medical treatment of infertility and men attending semen analysis. MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find potential differences. 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
- Infertility, Male
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2016to Nov 2023
- 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: Men contacting the fertility clinic in Turku University Hospital
Who may be able to join
- Ability to produce semen sample
Who cannot join
- Cognitive impairment
- Inadequate language skills for informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Men are recruited to collect seminal plasma samples and serum samples from men with azoospermia, men receiving medical treatment of infertility and men attending semen analysis. MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find potential differences. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry.
Read the detailed description
Azoospermic men attending microdissection testicular sperm extraction (MD-TESE) are group A. Second group (B) is the men with poor semen quality, who are treated with aromatase inhibitor, antiestrogen or human choriogonadotropic hormone (HCG) to improve semen quality. Third group (C) consists of men submitting semen analysis. The intended number of participants is 60, 60 and 100 men, respectively.
Seminal plasma and serum samples are collected and miRNA and piRNA are analyzed. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry. The participants are given a physical examination and testicular ultrasound. The primary aim of this study is to develop a tool to better estimate the sperm recovery rate (SRR) of azoospermic men scheduled for MD-TESE. Since no data have been published presenting miRNA and piRNA levels in men with normal semen, a secondary aim is to describe the levels of miRNA and piRNA in unselected men. Third part of this study aims to find if medical treatment improving semen parameters affects miRNA ja piRNA findings.
- Conditions
- Infertility, Male
- Keywords
- azoospermia, male fertility, MD-TESE, miRNA, piRNA, male infertility
- Medical subject headings
- Infertility, Male, Azoospermia
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 |
|---|---|---|
| MD-TESE (A) | Azoospermic men, MD-TESE operation (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound. | |
| Subfertile men (B) | Subfertile men receiving medication (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound. | |
| Control (C) | Control group, men scheduled for semen analysis. Semen sample, serum sample and physical examination with testicular ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA and piRNA according to sperm recovery in MD-TESE
Measured: Two years
Secondary outcomes (1)
Assess miRNA and pRNA changes with hormonal treatment
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2023
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Lund University Hospital, University of Turku
- Responsible party
- Sponsor
- Investigators
- Antti Perheentupa, MD,PhD, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932865
- Sponsor's protocol ID
- SemiFluid
- Acronym
- SemiFluid
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2016
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
- ClinicalTrials.gov ID
- NCT02932865
- Acronym / sponsor ID
- SemiFluid / SemiFluid
- Conditions
- Infertility, Male
- Keywords
- azoospermia, male fertility, MD-TESE, miRNA, piRNA, male infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Lund University Hospital, University of Turku
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 13 Oct 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.
Men are recruited to collect seminal plasma samples and serum samples from men with azoospermia, men receiving medical treatment of infertility and men attending semen analysis. MicroRNA (miRNA) and PiWi-interacting RNA (piRNA) are analyzed for all of the groups to find potential differences. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry.
Detailed description
Azoospermic men attending microdissection testicular sperm extraction (MD-TESE) are group A. Second group (B) is the men with poor semen quality, who are treated with aromatase inhibitor, antiestrogen or human choriogonadotropic hormone (HCG) to improve semen quality. Third group (C) consists of men submitting semen analysis. The intended number of participants is 60, 60 and 100 men, respectively.
Seminal plasma and serum samples are collected and miRNA and piRNA are analyzed. Steroid hormones are analyzed by liquid chromatography-tandem mass spectrometry. The participants are given a physical examination and testicular ultrasound. The primary aim of this study is to develop a tool to better estimate the sperm recovery rate (SRR) of azoospermic men scheduled for MD-TESE. Since no data have been published presenting miRNA and piRNA levels in men with normal semen, a secondary aim is to describe the levels of miRNA and piRNA in unselected men. Third part of this study aims to find if medical treatment improving semen parameters affects miRNA ja piRNA findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MD-TESE (A) | – | –Azoospermic men, MD-TESE operation (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound. |
| Subfertile men (B) | – | –Subfertile men receiving medication (standard treatment). Semen sample, serum sample and physical examination with testicular ultrasound. |
| Control (C) | – | –Control group, men scheduled for semen analysis. Semen sample, serum sample and physical examination with testicular ultrasound. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men contacting the fertility clinic in Turku University Hospital
Key inclusion criteria (1 listed)
- Ability to produce semen sample
Key exclusion criteria (2 listed)
- Cognitive impairment
- Inadequate language skills for informed consent
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
miRNA and piRNA according to sperm recovery in MD-TESE
Time frame: Two years
1 secondary outcome
Assess miRNA and pRNA changes with hormonal treatment
Time frame: two years
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 15 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Antti Perheentupa, MD,PhD study director
University of Turku
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 Infertility, Male, run by Turku University Hospital at 1 site in Finland.
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: finished, as of the sponsor's last update on 15 Nov 2023. 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 Finland. 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?
miRNA and piRNA according to sperm recovery in MD-TESE (time frame: Two years). 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 15 Nov 2023.