In Vitro Effects of Procyanidine on Semen Parameter and DFI

Aristotle University Of Thessaloniki

Status

Completed

Conditions

DNA Double Strand Break

Spermatogenesis and Semen Disorders

Treatments

Dietary Supplement: procyanidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03414164

UHR-12

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.