NCT02624076

Acupuncture for Unexplained Subfertiliy

A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,423 (estimated)
• Sponsor: Heilongjiang University of Chinese Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unexplained Infertility

Interventions

Type	Name	Description
OTHER	Acupuncture	semi-fixed protocol will be used including four local core points; conception vessel (CV) 3, CV 6, and stomach (ST) 29 bilaterally and four in the leg/feet; spleen (SP) 6, and SP 9 bilaterally. The core points CV 3, CV 6, ST 29, SP 6, and SP 9 are thereafter connected to electrical stimulator (Hwoto, China) and stimulated with low-frequency, 2Hz, 0.5 ms
OTHER	expectant management	one initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-01-01
• First posted: 2015-12-08
• Last updated: 2015-12-21

Locations

16 sites across 1 country: China