Acupuncture for Unexplained Subfertiliy

Unexplained Infertility Clinical Trial

— AURIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02624076
• Other study ID #: AURIS2015
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2015
• Last updated: December 17, 2015
• Start date: December 2015

Study information

• Verified date: December 2015
• Source: Heilongjiang University of Chinese Medicine
• Contact: Hui Chang, MD
• Email: changhui1903[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1423
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

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
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Hunan University of Chinese	Changsha	Hunan
China	Daqing Longnan hospital	Daqing	Heilongjiang
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	The Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Guangzhou Medical School First Affiliated Hospital	Guangzhou	Guangdong
China	Hangzhou Chinese Medicine Hospital	Hangzhou
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 Hospital, Jiangxi college of Chinese Medicine	Nanchang	Jiangxi
China	Jiangxi University of Chinese Medicine Affiliated Hospital	Nanchang	Jiangxi
China	Shanxi Chinese Medicine Hospital	Shangxi	Shanxi
China	Shanxi Hospital of Chinese Medicine	Taiyuan	Shanxi
China	First Affiliated Hospital of Tianjin University of Chinese Medicine	Tianjin	Tianjin
China	Tianjin Tanggu Maternity and Child Care Center	Tianjin	Tianjin
China	Wenzhou Chinese Medicine Hospital	Wenzhou	Zhejiang
China	Maternal and Child Health Hospital of Xuzhou	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate		Up to 4 months	No
Secondary	pregnancy rate		Up to 14 months	No
Secondary	Miscarriage rate		Up to 14 months	No
Secondary	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	No
Secondary	quality of life		Up to 14 months	No
Secondary	Side effect		Up to 14 months	No