In Vitro Effects of Procyanidine on Semen Parameters and DNA Fragmentation Index: a Prospective, Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Progressive sperm motility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
procyanidine group
干预措施: procyanidine (Dietary Supplement)
control group
结局指标
主要结局
Progressive sperm motility
时间窗: 3h after addition or not of procyanidine
percentage (%) of decrease
次要结局
- Sperm DNA fragmentation index(3h after addition or not of procyanidine)
- Sperm morphology(3h after addition or not of procyanidine)
- Sperm vitality(3h after addition or not of procyanidine)
研究者
E.M. Kolibianakis
Associate Professor
Aristotle University Of Thessaloniki