ACTRN12611000226909.

Trial name or title	Acupuncture compared to sham acupuncture and standard care to improve live birth rates for women undergoing IVF: a randomised controlled trial
Methods	Parallel design, randomised controlled trial
Participants	Women aged less than 43 years, undergoing a fresh IVF or ICSI cycle, and restricted to women with the potential for a lower live birth rate defined as > 2 previous unsuccessful embryo transfers (fresh or frozen), and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria
Interventions	Needle or sham acupuncture for 1 hr on day 6‐8 of the IVF cycle, plus two treatments on the day of the embryo transfer, 30 minutes before and after embryo transfer. Compared to no treatment control
Outcomes	Primary outcome: live birth ‐ defined as the delivery of one or more living infants, greater than 20 weeks gestation or 400 grams or more birth weight. Secondary outcomes: 1. clinical pregnancy defined as demonstration of fetal heart activity on ultrasound scan 2. miscarriage defined as a non viable pregnancy prior to 12 weeks gestation 3. quality of life 4. self efficacy
Starting date	Registration: 02/03/2011
Contact information	Caroline Smith Centre for Complementary Medicine Research University of Western Sydney Locked Bag 1797 Penrith South DC NSW 2751, Australia
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