In Vitro Effects of Procyanidine on Semen Parameter and DFI

Spermatogenesis and Semen Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414164
• Other study ID #: UHR-12
• Status: Completed
• Phase: N/A
• First received: October 24, 2017
• Last updated: January 26, 2018
• Start date: April 29, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• DNA Double Strand Break
• Spermatogenesis and Semen Disorders

Intervention

Dietary Supplement:
• procyanidine
natural antioxidants

Locations

Country	Name	City	State
Greece	Stratis Kolibianakis	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Sohag University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progressive sperm motility	percentage (%) of decrease	3h after addition or not of procyanidine
Secondary	Sperm DNA fragmentation index	percentage (%) of decrease	3h after addition or not of procyanidine
Secondary	Sperm morphology	percentage (%) of decrease	3h after addition or not of procyanidine
Secondary	Sperm vitality	percentage (%) of decrease	3h after addition or not of procyanidine