Clinical trial NCT03414164: In Vitro Effects of Procyanidine on Semen Parameter and DFI
Official title: In Vitro Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index: 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: 2018-01-29
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: 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.


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: 3h after addition or not of procyanidine
Secondary outcomes:
measure: Sperm DNA fragmentation index
timeFrame: 3h after addition or not of procyanidine
measure: Sperm morphology
timeFrame: 3h after addition or not of procyanidine
measure: Sperm vitality
timeFrame: 3h after addition or not of procyanidine
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Stratis Kolibianakis
Study officials:
References: