MedTrace Logo

Acupuncture for Unexplained Subfertiliy

NCT02624076 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1423

Last updated 2015-12-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Heilongjiang University of Chinese Medicine

    lead OTHER

Principal Investigators

  • Xiaoke Wu, MD.PhD. · The First Affliated Hospital,Heilongjiang University of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-01-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624076 on ClinicalTrials.gov