Status:
COMPLETED
In Vitro Effects of Procyanidine on Semen Parameter and DFI
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
Sohag University
Conditions:
Spermatogenesis and Semen Disorders
DNA Double Strand Break
Eligibility:
MALE
18-50 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03414164
Start Date
April 29 2017
End Date
December 31 2017
Last Update
January 29 2018
Active Locations (1)
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1
Stratis Kolibianakis
Thessaloniki, Greece, 54603