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OpenTrials
Completed

NCT Number: NCT03414164

In Vitro Effects of Procyanidine on Semen Parameter and DFI

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.

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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 antioxidants

Primary outcomes

  1. Progressive sperm motility

    Time frame: 3h after addition or not of procyanidine

    percentage (%) of decrease

Secondary outcomes

  1. Sperm DNA fragmentation index

    Time frame: 3h after addition or not of procyanidine

    percentage (%) of decrease

  2. Sperm morphology

    Time frame: 3h after addition or not of procyanidine

    percentage (%) of decrease

  3. Sperm vitality

    Time frame: 3h after addition or not of procyanidine

    percentage (%) of decrease

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Sohag University

Registry information

Official study title

In Vitro Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index: a Prospective, Double-blind Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2018
Registry last updated
Jan 29, 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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