Acupuncture for Unexplained Subfertiliy (AURIS)

Heilongjiang University of Chinese Medicine

Status: Unknown

Conditions: Unexplained Infertility

Treatments: Other: expectant management; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02624076

AURIS2015

Details and patient eligibility

About

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.

Enrollment: 1,423 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,423 participants in 2 patient groups

Acupuncture plus expectant management

Experimental group

Treatment:

Other: Acupuncture

Other: expectant management

expectant management

Active Comparator group

Treatment:

Other: expectant management