Status:
COMPLETED
Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index During Cryopreservation of Abnormal Human Semen Samples
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
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, inter...
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 :
August 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03451682
Start Date
August 3 2017
End Date
February 5 2018
Last Update
March 2 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stratis Kolibianakis
Thessaloniki, Greece, 54603