AURIS: Acupuncture for Unexplained Subfertiliy

• Sponsor: Heilongjiang University of Chinese Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02624076
• Collaborator: (none)
• Enrollment: 1,423
• Locations: 16
• Arms: 2
• Patients Per Site: 88.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unexplained Infertility	Other: Acupuncture; Other: expectant management	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1423 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
• Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Jan 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. live birth rate [Up to 4 months]

Secondary Outcome Measures

1. pregnancy rate [Up to 14 months]

2. Miscarriage rate [Up to 14 months]

3. 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]

4. quality of life [Up to 14 months]

5. Side effect [Up to 14 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Medical School First Affiliated Hospital	Guangzhou	Guangdong	China
2	The Daqing Oilfield General Hospital	Daqing	Heilongjiang	China	163000
3	Daqing Longnan hospital	Daqing	Heilongjiang	China
4	Daqing Oilfield General Hospital	Daqing	Heilongjiang	China
5	Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .	Harbin	Heilongjiang	China	150040
6	Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang	China	150040
7	First Affiliated Hospital of Hunan University of Chinese	Changsha	Hunan	China
8	Maternal and Child Health Hospital of Xuzhou	Xuzhou	Jiangsu	China
9	Jiangxi University of Chinese Medicine Affiliated Hospital	Nanchang	Jiangxi	China	330000
10	First Hospital, Jiangxi college of Chinese Medicine	Nanchang	Jiangxi	China
11	Shanxi Chinese Medicine Hospital	Shangxi	Shanxi	China	030012
12	Shanxi Hospital of Chinese Medicine	Taiyuan	Shanxi	China
13	Tianjin Tanggu Maternity and Child Care Center	Tianjin	Tianjin	China	300451
14	First Affiliated Hospital of Tianjin University of Chinese Medicine	Tianjin	Tianjin	China
15	Wenzhou Chinese Medicine Hospital	Wenzhou	Zhejiang	China	325000
16	Hangzhou Chinese Medicine Hospital	Hangzhou		China	310000

Sponsors and Collaborators

• Heilongjiang University of Chinese Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaoke Wu, Director of obstetrics and gynecology, First Affiliated Hospital of Heilongjiang Chinese Medicine University
• ClinicalTrials.gov Identifier: NCT02624076
• Other Study ID Numbers: AURIS2015
• First Posted: Dec 8, 2015
• Last Update Posted: Dec 21, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Xiaoke Wu, Director of obstetrics and gynecology, First Affiliated Hospital of Heilongjiang Chinese Medicine University: unexplained infertility; Acupuncture
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Dec 21, 2015