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Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples

Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples: a Prospective, Double-blind Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03451682
Enrollment
50
Registered
2018-03-02
Start date
2017-08-03
Completion date
2018-02-05
Last updated
2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DNA Double Strand Break, Spermatogenesis and Semen Disorders

Brief summary

Cryopreservation is the storage of biological material at subzero temperatures at which biochemical processes of cell metabolism and the biochemical reactions that lead to cell death are slowed, interrupted or stopped.Many investigators have focused on the use of antioxidants in the freezing media to reduce the negative effects of reactive oxygen species(ROS) on spermatozoa and in this context addition of vitamin E to cryoprotective medium enhanced the post-thaw sperm motility and preserved sperm DNA integrity , superoxide dismutase (SOD) and catalase (CAT) were added to boar spermatozoa freezing media and they not only increased sperm motility and viability but also decreased post-thaw ROS generation which led to improvement in results of in vitro fertilizing with thawed spermatozoa.However, the impact of in vitro addition of proanthocyanidins to human semen before cryopreservation on post-thawing semen parameters, DFI 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 before cryopreservation, differ in post-thawing semen parameters and sperm DNA fragmentation index (DFI).

Interventions

DIETARY_SUPPLEMENTprocyanidine

Natural antioxidant

Sponsors

Sohag University
CollaboratorOTHER
Aristotle University Of Thessaloniki
Lead SponsorOTHER

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

MeasureTime frameDescription
Progressive sperm motility3 Hours after ejaculation and immediately after thawing with or without Procyanidinepercentage (%) of decrease

Secondary

MeasureTime frameDescription
Sperm DNA fragmentation index3 Hours after ejaculation and immediately after thawing with or without Procyanidinepercentage (%) of increase
Sperm morphology3 Hours after ejaculation and immediately after thawing with or without Procyanidinepercentage (%) of decrease
Sperm vitality3 Hours after ejaculation and immediately after thawing with or without Procyanidinepercentage (%) of decrease

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026