Impact of Duloxetine on Male Fertility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks
研究概览
简要总结
The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes measured will include semen parameters (sperm concentration, motility, morphology), hormone levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ) surveys.
详细描述
Antidepressant medications are commonly prescribed in the USA not only for depression, but also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain. Despite being widely prescribed in the United States in men of reproductive age, the impact of antidepressants on fertility has not been extensively studied.
After noticing worsened semen parameters in men on anti-depressants, the investigators performed the first prospective study to demonstrate a deleterious impact of selective serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs on male fertility, as assessed by semen parameters and/or sperm DNA integrity.
No studies have examined the impact of a newer, but similar, class of antidepressant - the serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is one of the most commonly prescribed anti-depressants in the United States.
The investigators are conducting this trial to determine whether or not the administration of duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged 18-65 years old;
- •normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm motility > 30%, sperm morphology > 3%);
- •willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;
- •capable of providing semen sample.
排除标准
- •Clinically detected varicocele;
- •oligoasthenoteratospermia or azoospermia on semen analysis;
- •ongoing attempts to initiate pregnancy;
- •current sexual dysfunction (classified as moderate or worse on IIEF);
- •history of seizure disorder;
- •history of previous chemotherapy or radiation therapy;
- •current psychiatric history or history of bipolar disorder;
- •family history of bipolar disorder, depression, or suicide;
- •use of any psychotropic medications or anticonvulsants;
- •use of sleeping pills more than once per week;
- •use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;
- •use of medications which may affect hormone measures and/or sexual function;
- •inability to read, follow instructions, or complete questionnaires in English;
- •consumption of tobacco or illicit drugs;
- •consumption of >2oz of alcohol daily.
研究组 & 干预措施
Duloxetine
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
干预措施: Duloxetine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks
时间窗: 6 Weeks (primary time point of interest)
Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks
时间窗: 0 weeks
Number of participants with Tunel Values \> 25% at 0 Weeks (baseline) in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks
时间窗: 2 weeks
Number of participants with Tunel values \> 25% at 2 weeks in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks
时间窗: 8 weeks
Number of participants with Tunel values \> 25% at 8 weeks in each treatment group
Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks
时间窗: 10 Weeks
Number of participants with Tunel values \> 25% at 10 weeks in each treatment group
次要结局
- Sperm Motility at 0 Weeks(0 weeks)
- Sperm Tail Defects at 0 Weeks(0 weeks)
- Sperm Concentration at 10 Weeks(10 Weeks)
- Sperm Concentration at 0 Weeks(0 weeks)
- Sperm Concentration at 2 Weeks(2 weeks)
- Sperm Concentration at 6 Weeks(6 weeks)
- Sperm Concentration at 8 Weeks(8 weeks)
- Sperm Motility at 10 Weeks(10 Weeks)
- Sperm Neck Defects at 8 Weeks(8 weeks)
- Sperm Motility at 2 Weeks(2 weeks)
- Sperm Motility at 8 Weeks(8 weeks)
- Sperm Head Defects at 0 Weeks(0 weeks)
- Sperm Motility at 6 Weeks(6 weeks)
- Sperm Head Defects at 2 Weeks(2 weeks)
- Sperm Head Defects at 6 Weeks(6 weeks)
- Sperm Head Defects at 8 Weeks(8 weeks)
- Sperm Head Defects at 10 Weeks(10 Weeks)
- Sperm Neck Defects at 0 Weeks(0 weeks)
- Sperm Neck Defects at 2 Weeks(2 weeks)
- Sperm Neck Defects at 6 Weeks(6 weeks)
- Sperm Neck Defects at 10 Weeks(10 Weeks)
- Sperm Tail Defects at 2 Weeks(2 weeks)
- Sperm Tail Defects at 6 Weeks(6 weeks)
- Sperm Tail Defects at 8 Weeks(8 weeks)
- Sperm Tail Defects at 10 Weeks(10 Weeks)
- Testosterone Level at 0 Weeks(0 weeks)
- Testosterone Level at 2 Weeks(2 weeks)
- Testosterone Level at 6 Weeks(6 weeks)
- Testosterone Level at 8 Weeks(8 weeks)
- Testosterone Level at 10 Weeks(10 Weeks)
- Estrogen Level at 0 Weeks(0 weeks)
- Estrogen Level at 2 Weeks(2 weeks)
- Estrogen Level at 6 Weeks(6 weeks)
- Estrogen Level at 8 Weeks(8 weeks)
- Estrogen Level at 10 Weeks(10 Weeks)
- Prolactin Level at 0 Weeks(0 weeks)
- Prolactin Level at 2 Weeks(2 weeks)
- Prolactin Level at 6 Weeks(6 weeks)
- Prolactin Level at 8 Weeks(8 weeks)
- Prolactin Level at 10 Weeks(10 Weeks)
- Luteinizing Hormone Level at 0 Weeks(0 weeks)
- Luteinizing Hormone Level at 2 Weeks(2 weeks)
- Luteinizing Hormone Level at 6 Weeks(6 weeks)
- Luteinizing Hormone Level at 8 Weeks(8 weeks)
- Luteinizing Hormone Level at 10 Weeks(10 Weeks)
- Follicle Stimulating Hormone Level at 0 Weeks(0 weeks)
- Follicle Stimulating Hormone Level at 2 Weeks(2 weeks)
- Follicle Stimulating Hormone Level at 6 Weeks(6 weeks)
- Follicle Stimulating Hormone Level at 8 Weeks(8 weeks)
- Follicle Stimulating Hormone Level at 10 Weeks(10 Weeks)