Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples

NCT ID: NCT03451682

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2018-02-05

Brief Summary

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).

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 antioxidant

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

procyanidine

Natural antioxidant

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-14

Identifier Type: -

Identifier Source: org_study_id