CompletedNot Applicable

In Vitro Effects of Procyanidine on Semen Parameter and DFI

Greece50 participantsStarted 2017-04-29

Plain-language 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 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.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progressive sperm motility

Timeframe: 3h after addition or not of procyanidine

Trial details

NCT IDNCT03414164

SponsorAristotle University Of Thessaloniki

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-30

View on ClinicalTrials.gov More Spermatogenesis and Semen Disorders trials