DNA Double Strand Break, Spermatogenesis and Semen Disorders
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTprocyanidine
natural antioxidants
Sponsors
Sohag University
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progressive sperm motility | 3h after addition or not of procyanidine | percentage (%) of decrease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm vitality | 3h after addition or not of procyanidine | percentage (%) of decrease |
| Sperm DNA fragmentation index | 3h after addition or not of procyanidine | percentage (%) of decrease |
| Sperm morphology | 3h after addition or not of procyanidine | percentage (%) of decrease |
Countries
Greece
Outcome results
None listed