NCT03451682

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

February 20, 2018

Last Update Submit

February 24, 2018

Conditions

Spermatogenesis and Semen DisordersDNA Double Strand Break

Outcome Measures

Primary Outcomes (1)

  • Progressive sperm motility

    percentage (%) of decrease

    3 Hours after ejaculation and immediately after thawing with or without Procyanidine

Secondary Outcomes (3)

  • Sperm DNA fragmentation index

    3 Hours after ejaculation and immediately after thawing with or without Procyanidine

  • Sperm morphology

    3 Hours after ejaculation and immediately after thawing with or without Procyanidine

  • Sperm vitality

    3 Hours after ejaculation and immediately after thawing with or without Procyanidine

Study Arms (2)

procyanidine group

EXPERIMENTAL
Dietary Supplement: procyanidine

Control group

NO INTERVENTION

Interventions

procyanidineDIETARY_SUPPLEMENT

Natural antioxidant

procyanidine group

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stratis Kolibianakis

Thessaloniki, 54603, Greece

Location

MeSH Terms

Interventions

procyanidin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 2, 2018

Study Start

August 3, 2017

Primary Completion

January 10, 2018

Study Completion

February 5, 2018

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

GR(1)