In Vitro Effects of Procyanidine on Semen Parameter and DFI

NCT ID: NCT03414164

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-29
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

procyanidine group

Group Type: EXPERIMENTAL

procyanidine

Intervention Type: DIETARY_SUPPLEMENT

natural antioxidants

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

procyanidine

natural antioxidants

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

E.M. Kolibianakis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stratis Kolibianakis

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

UHR-12

Identifier Type: -

Identifier Source: org_study_id