CClinicalTrials.gg
Sign In
CompletedNCT03451682Updated Mar 2, 2018

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

An interventional study of procyanidine in Spermatogenesis and Semen Disorders and DNA Double Strand Break, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-03-02.

Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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).

02

Conditions studied

  • Spermatogenesis and Semen Disorders
  • DNA Double Strand Break
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    procyanidine group

    Dietary Supplement: procyanidine

  • No intervention
    Control group

Interventions

  • Dietary supplementprocyanidine

    Natural antioxidant

05

What researchers measure

Primary outcomes

  1. Progressive sperm motility

    percentage (%) of decrease

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

Secondary outcomes

  1. Sperm DNA fragmentation index

    percentage (%) of increase

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

  2. Sperm morphology

    percentage (%) of decrease

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

  3. Sperm vitality

    percentage (%) of decrease

    Time frame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine

06

Study locations

1 site
  • Stratis Kolibianakis
    Thessaloniki, 54603, Greece
07

Registry details

Key details

Study ID
NCT03451682
Lead sponsor
Aristotle University Of Thessaloniki
Collaborators
Sohag University
Responsible party
E.M. Kolibianakis (Associate Professor, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Mar 2, 2018
Start date
Aug 3, 2017
Primary completion
Jan 10, 2018
Completion
Feb 5, 2018
Last update
Mar 2, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Aristotle University Of Thessaloniki

Start the discussion