Hyperbaric Oxygen Therapy for Men Suffering From Infertility Due to Oligospermia: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Sperm count
研究概览
简要总结
Infertility in a couple is defined as the inability to achieve conception despite one year of frequent, unprotected intercourse. Infertility affects approximately 12% of couples attempting to conceive. The goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.
详细描述
Infertility in a couple is defined as the inability to achieve conception despite one year of frequent, unprotected intercourse. Infertility affects approximately 12% of couples attempting to conceive. The male factor is equally attribute to couple infertility like woman infertility.
Male infertil¬ity may have many reasons. In up to 90% of male infertility cases, there is a decrease in sperm count or the might show poor sperm quality. During spermatogenesis, mitochondria undergo continuous morphological and distributional changes with germ cell development. Deficiencies in these processes lead to mitochondrial dysfunction and abnormal spermatogenesis, thereby causing male infertility.
In addition to mitochondria, telomer also play a significant role in sperm functionality. Telomere length is considered one of the most relevant biological markers of genomic stability. The negative impact of telomere shortening on sperm quality has been suggested as an important indicator of male infertility.
It is now understood that Hyperbaric oxygen treatment (HBOT), triggers both oxygen and pressure sensitive genes, resulting in inducing mitochondrial proliferation, increase in complex I activity and those mitochondrial efficiency. With respect to telomers, in a recent study, it was demonstrated that HBOT can induce telomeres elongation.
The goal of this study is to explore the potential beneficial effect of HBOT on sperm count of infertile male due to oligospermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age above 21 years
- •At least two sperm examination showing oligospermia (<15·106 sperm/mL)
- •Diagnosis of idiopathic oligospermia.
- •Subject willing and able to read, understand and sign an informed consent
排除标准
- •Inability to attend scheduled clinic visits and/or comply with the study protocol
- •Active malignancy
- •Previous treatment with chemotherapy and/or radiation therapy
- •Substance use at baseline
- •Severe or unstable physical disorders or major cognitive deficits at baseline
- •HBOT for any reason prior to study enrolment
- •Chest pathology incompatible with pressure changes (including moderate to severe asthma)
- •Ear or Sinus pathology incompatible with pressure changes
- •Chronic disease like diabetes mellitus, ischemic heart disease etc.
- •Active smoking
研究组 & 干预措施
Hyperbaric Oxygen Therapy active arm
The protocol comprises of 60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period.
干预措施: Hyperbaric oxygen therapy (Device)
结局指标
主要结局
Sperm count
时间窗: At baseline, 3 months
Change from baseline in sperm count measured by Sperm Analysis
次要结局
- Sperm count(9 months)
- Sperm morphology(At baseline, 3 months, 9 months)
- Sperm motility(At baseline, 3 months, 9 months)
- Sperm telomeres length(At baseline, 3 months, 9 months)
- Lymphocyte telomeres length(At baseline, 3 months, 9 months)
研究者
Shay Efrati
MD
Assaf-Harofeh Medical Center