Table 3. Prespecified Secondary Clinical Outcomes by Study Group.
| Prespecified Secondary Outcome | No./Total No. (%) | Risk Difference, % (95% CI) |
Relative Risk (95% CI) | P Valuea | |
|---|---|---|---|---|---|
| Acupuncture | Sham Acupuncture Control | ||||
| Clinical pregnancy among participants in the primary analysis cohort | 105/408 (25.7) | 88/406 (21.7) | 4.1 (−1.8 to 9.9) | 1.19 (0.93 to 1.52) | .17 |
| Post hoc sensitivity analysis | |||||
| Best case for acupunctureb | 112/415 (27.0) | 88/409 (21.5) | 5.5 (−0.3 to 11.3) | 1.25 (0.98 to 1.60) | .07 |
| Worst case for acupuncturec | 105/415 (25.3) | 91/409 (22.3) | 3.1 (−2.8 to 8.9) | 1.14 (0.89 to 1.45) | .30 |
| Post hoc exploratory analyses | |||||
| Clinical pregnancy among participants receiving an embryo transfer | 101/301 (33.6) | 86/307 (28.0) | 5.5 (−1.8 to 12.9) | 1.20 (0.94 to 1.52) | .14 |
| Miscarriage among clinical pregnancy | 23/101 (22.8) | 10/86 (11.6) | 11.1 (0.5 to 21.8) | 1.96 (0.99 to 3.88) | .054 |
| Women who reported any adverse event | 87/301 (28.9) | 65/307 (21.2) | 7.7 (0.9 to 14.6) | 1.37 (1.03 to 1.81) | .03 |
| Tiredness | 44/301 (14.6) | 36/307 (11.7) | 2.9 (−2.5 to 8.3) | 1.25 (0.83 to 1.88) | .29 |
| Discomfort on day of embryo transfer | 31/301 (10.3) | 15/307 (4.9) | 5.4 (1.2 to 9.6) | 2.11 (1.16 to 3.82) | .01 |
| Dizziness or drowsiness | 17/301 (5.7) | 14/307 (4.6) | 1.1 (−2.4 to 4.6) | 1.23 (0.62 to 2.47) | .67 |
| Pain | 15/301 (5.0) | 10/307 (3.3) | 1.7 (−1.4 to 4.9) | 1.53 (0.70 to 3.35) | .29 |
| Bruising | 15/301 (5.0) | 4/307 (1.3) | 3.7 (0.9 to 6.5) | 3.82 (1.28 to 11.39) | .02 |
| Nausea or vomiting | 8/301 (2.6) | 4/307 (1.3) | 1.4 (−0.9 to 3.6) | 2.04 (0.62 to 6.70) | .24 |
| Headaches | 7/301 (2.3) | 7/307 (2.3) | 0.1 (−2.3 to 2.4) | 1.02 (0.36 to 2.87) | .97 |
| Diarrhea | 4/301 (1.3) | 2/307 (0.7) | 0.7 (−0.9 to 2.3) | 2.04 (0.38 to 11.05) | .41 |
| Otherd | 6/301 (1.9) | 5/307 (1.6) | 0.4 (−1.8 to 2.5) | 1.22 (0.38 to 3.97) | .74 |
a
Testing for evidence of departure from relative risk = 1 using a Wald-type test.
b
Assuming all unknown events in the acupuncture group were positive and those in the sham acupuncture group were negative.
c
Assuming none of the women with missing data in the acupuncture group became pregnant, and all of the women with missing data in the sham acupuncture group did become pregnant.
d
Other includes sweating, skin irritation, or numbness.