In Vitro Effects of Procyanidine on Semen Parameter and DFI

Not Applicable

Completed

• Conditions: Spermatogenesis and Semen Disorders; DNA Double Strand Break
• Interventions: Dietary Supplement: procyanidine

• Registration Number: NCT03414164
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-29
• Study First Submitted: 2017-10-24
• Primary Completion: 2017-11-30
• Study Completion: 2017-12-31
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-26
• Last Update Submitted: 2018-01-26
• Study First Posted: 2018-01-29
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
procyanidine group	procyanidine	-

Primary Outcome Measures

Name	Time	Method
Progressive sperm motility	3h after addition or not of procyanidine	percentage (%) of decrease

Secondary Outcome Measures

Name	Time	Method
Sperm DNA fragmentation index	3h after addition or not of procyanidine	percentage (%) of decrease
Sperm vitality	3h after addition or not of procyanidine	percentage (%) of decrease
Sperm morphology	3h after addition or not of procyanidine	percentage (%) of decrease

Trial Locations

Locations (1)

Stratis Kolibianakis; 🇬🇷 Thessaloniki, Greece