Acupuncture for Unexplained Subfertiliy

Not Applicable

• Conditions: Unexplained Infertility

• Registration Number: NCT02624076
• Lead Sponsor: Heilongjiang University of Chinese Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-24
• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-21
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1423

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
live birth rate	Up to 4 months

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate	Up to 14 months
quality of life	Up to 14 months
pregnancy rate	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

Trial Locations

Locations (16)

Guangzhou Medical School First Affiliated Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

Daqing Longnan hospital; 🇨🇳 Daqing, Heilongjiang, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .; 🇨🇳 Harbin, Heilongjiang, China

Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine; 🇨🇳 Harbin, Heilongjiang, China

First Affiliated Hospital of Hunan University of Chinese; 🇨🇳 Changsha, Hunan, China

Maternal and Child Health Hospital of Xuzhou; 🇨🇳 Xuzhou, Jiangsu, China

Jiangxi University of Chinese Medicine Affiliated Hospital; 🇨🇳 Nanchang, Jiangxi, China

First Hospital, Jiangxi college of Chinese Medicine; 🇨🇳 Nanchang, Jiangxi, China

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