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Completed

NCT Number: NCT03451682

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

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).

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Key information

Conditions

Spermatogenesis and Semen Disorders DNA Double Strand Break

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stratis Kolibianakis

Thessaloniki, 54603, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

procyanidine

Dietary Supplement

Natural antioxidant

Primary outcomes

  1. Progressive sperm motility

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

    percentage (%) of decrease

Secondary outcomes

  1. Sperm DNA fragmentation index

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

    percentage (%) of increase

  2. Sperm morphology

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

    percentage (%) of decrease

  3. Sperm vitality

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

    percentage (%) of decrease

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Sohag University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2018
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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