In Vitro Effects of Procyanidine on Semen Parameter and DFI

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

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.

Study Overview

• Status: Completed
• Conditions: Spermatogenesis and Semen Disorders; DNA Double Strand Break
• Intervention / Treatment: Dietary supplement: procyanidine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54603
    • Stratis Kolibianakis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: procyanidine group	Dietary supplement: procyanidine; natural antioxidants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive sperm motility	percentage (%) of decrease	3h after addition or not of procyanidine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm DNA fragmentation index	percentage (%) of decrease	3h after addition or not of procyanidine
Sperm morphology	percentage (%) of decrease	3h after addition or not of procyanidine
Sperm vitality	percentage (%) of decrease	3h after addition or not of procyanidine

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Sohag University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2017
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Procyanidin
• Other Study ID Numbers: UHR-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No