A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,423
- 试验地点
- 16
- 主要终点
- live birth rate
研究概览
简要总结
Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Acupuncture is being increasingly used by couples with all types of infertility and initial trials have suggested that it could be potentially beneficial in some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting results, but there is no evidence to inform best practice in unexplained infertility. In addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could have the potential to increase live birth rates in women with unexplained infertility, the clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a large randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-40 years
- •Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
- •Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)
排除标准
- •Unwillingness to accept either of the two interventions
- •Contra-indications to acupuncture: pacemaker use or bleeding disorder
- •Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
- •Previously received acupuncture for unexplained infertility
- •Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
- •Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).
研究组 & 干预措施
Acupuncture plus expectant management
干预措施: Acupuncture (Other)
Acupuncture plus expectant management
干预措施: expectant management (Other)
expectant management
干预措施: expectant management (Other)
结局指标
主要结局
live birth rate
时间窗: Up to 4 months
次要结局
- pregnancy rate(Up to 14 months)
- Miscarriage rate(Up to 14 months)
- quality of life(Up to 14 months)
- Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.(Up to 14 months)
- Side effect(Up to 14 months)
研究者
Xiaoke Wu
Director of obstetrics and gynecology
First Affiliated Hospital of Heilongjiang Chinese Medicine University