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

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).

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: 14 years to 46 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 Assignment
• 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 antioxidant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive sperm motility	percentage (%) of decrease	3 Hours after ejaculation and immediately after thawing with or without Procyanidine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm DNA fragmentation index	percentage (%) of increase	3 Hours after ejaculation and immediately after thawing with or without Procyanidine
Sperm morphology	percentage (%) of decrease	3 Hours after ejaculation and immediately after thawing with or without Procyanidine
Sperm vitality	percentage (%) of decrease	3 Hours after ejaculation and immediately after thawing with or without Procyanidine

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): February 5, 2018

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 24, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 24, 2018
• Last Verified: February 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-14

Drug and device information, study documents

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