OBJECTIVE:
To evaluate the influence of "true" versus "sham" acupuncture on pregnancy rates (PRs) in women undergoing IVF.

DESIGN:
Randomized controlled trial, double-blinded with independent observer.

SETTING:
Academic infertility clinic.

PATIENT(S):
One hundred sixty patients <38 years old undergoing IVF with or without intracytoplasmic sperm injection.

INTERVENTION(S):
Subjects were randomly allocated to the true or sham group and underwent acupuncture 25 minutes before and after ET. Subjects completed a McGill Pain Questionnaire regarding their clinical symptoms during ET.

MAIN OUTCOME MEASURE(S):
Clinical PR and clinical symptoms during ET.

RESULT(S):
While the overall clinical PR was 51.25%, there was no significant difference between the arms of the study (true = 45.3% vs. sham = 52.7%); 33.1% of the patients had ultrasound-documented singleton pregnancy, and 15% of patients had twin gestations, while one patient in the true arm had a triplet gestation. There were significant differences in the subjective, affective, and total pain experience between both arms. The subjects in the true arm described their acupuncture session as being more "tiring" and "fearful" and experienced more "achiness" compared with their sham counterparts.

CONCLUSION(S):
There was no statistically significant difference in the clinical or chemical PRs between both groups. Patients undergoing true acupuncture had differing sensory experiences compared with patients in the sham arm. There were no significant adverse effects observed during the study, suggesting that acupuncture is safe for women undergoing ET.