Acupuncture for Unexplained Subfertiliy (AURIS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Unexplained Infertility
• Intervention / Treatment: Other: Acupuncture; Other: expectant management

• Study Type: Interventional
• Enrollment (Anticipated): 1423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China, 310000
    • Hangzhou Chinese Medicine Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou Medical School First Affiliated Hospital
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163000
      • The Daqing Oilfield General Hospital
    • Daqing, Heilongjiang, China
      • Daqing Oilfield General hospital
    • Daqing, Heilongjiang, China
      • Daqing Longnan hospital
    • Harbin, Heilongjiang, China, 150040
      • Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
    • Harbin, Heilongjiang, China, 150040
      • Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
  • Hunan
    • Changsha, Hunan, China
      • First Affiliated Hospital of Hunan University of Chinese
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Maternal and Child Health Hospital of Xuzhou
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Jiangxi University of Chinese Medicine Affiliated Hospital
    • Nanchang, Jiangxi, China
      • First Hospital, Jiangxi college of Chinese Medicine
  • Shanxi
    • Shangxi, Shanxi, China, 030012
      • Shanxi Chinese Medicine Hospital
    • Taiyuan, Shanxi, China
      • Shanxi Hospital of Chinese Medicine
  • Tianjin
    • Tianjin, Tianjin, China, 300451
      • Tianjin Tanggu Maternity and Child Care Center
    • Tianjin, Tianjin, China
      • First Affiliated Hospital of Tianjin University of Chinese Medicine
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Wenzhou Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria

1. Women aged 18-40 years
2. Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
3. Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)

Exclusion criteria

1. Unwillingness to accept either of the two interventions
2. Contra-indications to acupuncture: pacemaker use or bleeding disorder
3. Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
4. Previously received acupuncture for unexplained infertility
5. Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
6. Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture plus expectant management	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.
Active Comparator: expectant management	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
live birth rate	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
pregnancy rate	Up to 14 months
Miscarriage 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
quality of life	Up to 14 months
Side effect	Up to 14 months

Collaborators and Investigators

• Sponsor: Heilongjiang University of Chinese Medicine
• Investigators: Study Chair: Xiaoke Wu, MD.PhD., The First Affliated Hospital,Heilongjiang University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Acupuncture; unexplained infertility
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: AURIS2015