Spermatogenesis and Semen DisordersNCT03414164
In Vitro Effects of Procyanidine on Semen Parameter and DFI
A study testing procyanidine in people with Spermatogenesis and Semen Disorders and DNA Double Strand Break, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Proanthocyanidins are a class of polyphenols found in a variety of plants that have antioxidant activity in vitro, which is stronger than vitamin C or vitamin E. Several studies have been performed evaluating the administration of antioxidant therapy in the form of oral antioxidant supplementation or in vitro addition… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Spermatogenesis and Semen Disorders, DNA Double Strand Break
- What is being tested?
- procyanidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 29 Apr 2017to 31 Dec 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Infertility defined as:
- At least twelve (12) months of non-achieving pregnancy despite unprotected sexual intercourse or six (6) months, if the female is > 35 years of age AND
- At least two (2) semen analyses with at least one abnormal parameter (sperm concentration, motility and morphology), according to WHO 2010 criteria.
- Not on any type of infertility treatment for the last three (3) months
- Sperm concentration > 8 x 106/ml and semen volume at least 2.5 ml for technical reasons.
- Normal hormonal profile (TSH, FSH, LH, total testosterone, prolactin)
- Seminal white blood cells < 1 x 106/ml
- No abnormalities in scrotal ultrasound
Who cannot join
- Underlying genetic cause of infertility
- History of undescended testis (cryptorchidism)
- History of orchidectomy
- History of testicular cancer
- History of severe cardiac, hepatic or renal disease.
- History of endocrine disease (primary or secondary hypogonadism, hyperprolactinemia, thyroid disease, pituitary or adrenal disease)
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- History of epididymo-orchitis, prostatitis, genital trauma, testicular torsion, inguinal or genital surgery
- History of systemic disease or treatment during the last three (3) months
- Positive sperm culture for Chlamydia or Ureaplasma urealyticum
- Female infertility factors
- Body mass index (BMI) > 30 kg/m2
- Participation in another interventional study and a likelihood of being unavailable for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index: a Prospective, Double-blind Trial
Proanthocyanidins are a class of polyphenols found in a variety of plants that have antioxidant activity in vitro, which is stronger than vitamin C or vitamin E.
Several studies have been performed evaluating the administration of antioxidant therapy in the form of oral antioxidant supplementation or in vitro addition of antioxidant to culture media during assisted reproductive techniques (ART).
However, the impact of in vitro addition of proanthocyanidins to semen has not been studied yet. The research question evaluated in the current study was whether semen samples of infertile men supplemented or not with procyanidine immediately after their production, differ in semen parameters, sperm DFI.
- Being tested
- procyanidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procyanidineDietary supplement
natural antioxidants
| Study group | Role | What they receive |
|---|---|---|
| procyanidine group | Experimental | Not described Receives: Dietary Supplement: procyanidine |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive sperm motility
percentage (%) of decrease
Measured: 3h after addition or not of procyanidine
Secondary outcomes (3)
Sperm DNA fragmentation index
percentage (%) of decrease
Measured: 3h after addition or not of procyanidine
Sperm morphology
percentage (%) of decrease
Measured: 3h after addition or not of procyanidine
Sperm vitality
percentage (%) of decrease
Measured: 3h after addition or not of procyanidine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start29 Apr 2017
- Primary completion30 Nov 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spermatogenesis and Semen DisordersStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag University
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414164
- Sponsor's protocol ID
- UHR-12
- Status last verified
- Jan 2018
- First submitted
- 24 Oct 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index: a Prospective, Double-blind Trial
- ClinicalTrials.gov ID
- NCT03414164
- Acronym / sponsor ID
- UHR-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Sohag University
- Study start
- 29 Apr 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 29 Jan 2018 (actual)
- 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.
Proanthocyanidins are a class of polyphenols found in a variety of plants that have antioxidant activity in vitro, which is stronger than vitamin C or vitamin E.
Several studies have been performed evaluating the administration of antioxidant therapy in the form of oral antioxidant supplementation or in vitro addition of antioxidant to culture media during assisted reproductive techniques (ART).
However, the impact of in vitro addition of proanthocyanidins to semen has not been studied yet. The research question evaluated in the current study was whether semen samples of infertile men supplemented or not with procyanidine immediately after their production, differ in semen parameters, sperm DFI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| procyanidine group | Experimental | Dietary Supplement: procyanidine |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Infertility defined as:
- Not on any type of infertility treatment for the last three (3) months
- Sperm concentration > 8 x 106/ml and semen volume at least 2.5 ml for technical reasons.
- Normal hormonal profile (TSH, FSH, LH, total testosterone, prolactin)
- Seminal white blood cells < 1 x 106/ml
Key exclusion criteria (12 listed)
- Underlying genetic cause of infertility
- History of undescended testis (cryptorchidism)
- History of orchidectomy
- History of testicular cancer
- History of severe cardiac, hepatic or renal 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 |
|---|---|---|
| procyanidinenatural antioxidants | Dietary supplement | procyanidine group |
Primary outcome
Progressive sperm motility
Time frame: 3h after addition or not of procyanidine
percentage (%) of decrease
3 secondary outcomes
Sperm DNA fragmentation index
Time frame: 3h after addition or not of procyanidine
Sperm morphology
Time frame: 3h after addition or not of procyanidine
Sperm vitality
Time frame: 3h after addition or not of procyanidine
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 29 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procyanidine in people with Spermatogenesis and Semen Disorders and DNA Double Strand Break, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 8 inclusion and 12 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 29 Jan 2018. 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 Greece. 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?
Progressive sperm motility (time frame: 3h after addition or not of procyanidine). 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 29 Jan 2018.