In Vitro Effects of Procyanidine on Semen Parameter and DFI

Study Overview
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Brief Summary
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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.

Official Title
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In Vitro Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index: a Prospective, Double-blind Trial

Conditions
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Spermatogenesis and Semen Disorders, DNA Double Strand Break

Intervention / Treatment
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* Dietary Supplement: procyanidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: procyanidine group<br> | Dietary Supplement: procyanidine<br>* natural antioxidants<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive sperm motility | percentage (%) of decrease | 3h after addition or not of procyanidine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm DNA fragmentation index | percentage (%) of decrease | 3h after addition or not of procyanidine | 
| Sperm morphology | percentage (%) of decrease | 3h after addition or not of procyanidine | 
| Sperm vitality | percentage (%) of decrease | 3h after addition or not of procyanidine |