In Vitro Effects of Procyanidine on Semen Parameter and DFI

NCT03414164 | Completed

• 1 other identifier: UHR-12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spermatogenesis and Semen Disorders; DNA Double Strand Break

Outcome Measures

Primary Outcomes (1)

• Progressive sperm motility

  percentage (%) of decrease

  3h after addition or not of procyanidine

Secondary Outcomes (3)

• Sperm DNA fragmentation index

  3h after addition or not of procyanidine

• Sperm morphology

  3h after addition or not of procyanidine

• Sperm vitality

  3h after addition or not of procyanidine

Study Arms (2)

procyanidine group

EXPERIMENTAL

Dietary Supplement: procyanidine

control group

NO INTERVENTION

Interventions

procyanidine DIETARY_SUPPLEMENT

natural antioxidants

procyanidine group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Sohag University: collaborator

Study Sites (1)

Stratis Kolibianakis

Thessaloniki, 54603, Greece

Location

MeSH Terms

Interventions

procyanidin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: January 29, 2018
• Study Start: April 29, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 31, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

GR (1)