Clinical trial NCT03451682: Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples
Official title: Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples: a Prospective, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spermatogenesis and Semen Disorders
DNA Double Strand Break
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Sohag University
First posted: 2018-03-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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.

Primary outcomes:
measure: Progressive sperm motility
timeFrame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine
Secondary outcomes:
measure: Sperm DNA fragmentation index
timeFrame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine
measure: Sperm morphology
timeFrame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine
measure: Sperm vitality
timeFrame: 3 Hours after ejaculation and immediately after thawing with or without Procyanidine
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Stratis Kolibianakis
Study officials:
References: