Chan 2006.
| Methods | Randomised controlled trial | |
| Participants | Women who attended the Assisted Reproduction unit in Hong Kong for the first cycle of IVF. The women were primary or secondary subfertile. Mean (SD) age of the subfertile women was 36.0 (3.28) years in the intervention group and 35.0 (3.49) years in the control group. The duration of subfertility was 5.0 (2.0 to 11.0) years in the intervention group and 5.0 (1.0 to 15.0) years in the control group. 227 women were randomised into the intervention group (n = 101) and into the control group (n = 126) | |
| Interventions | The intervention group received the EBMS (Eastern Body‐Mind‐Spirit) approach, including mini‐lectures on traditional Chinese medicine, stress‐reduction training, activities, and reading materials for 12 hours. The intervention consisted of group therapy, delivered before fertility treatment, both face to face and written information, delivered by Chan, an experienced practitioner of EMBS. The control group received no intervention |
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| Outcomes | Clinical pregnancy, ongoing pregnancy (measured at 8 to 10 weeks gestation), anxiety (measured by C‐STAI), childbearing importance (self and marriage, measured by Childbearing Importance Index). Measured during recruitment (T1), on the first day of ovarian simulation (T2), and on the day of ET (T3) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomization process was performed according to well‐established guidelines." "Drawing lots achieved randomization." |
| Allocation concealment (selection bias) | Unclear risk | “Participants were notified of their group assignment individually.” However, the researchers could have known the allocation sequence |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No blinding of participants and personnel. Subjective outcomes are likely to be influenced |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | No blinding of participants and personnel. Pregnancy rates could be influenced |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Outcome assessor not blinded, may affect reporting of subjective outcomes |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Assessor not blinded, but fewer women missing from control group. Greater attempts of intervention group follow‐up than of control group follow up, which could lead to bias, will be unlikely in this case |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawal > 20% and not balanced between groups. No intention‐to‐treat analysis, only reported on those who did not drop out of the intervention |
| Selective reporting (reporting bias) | Unclear risk | Unclear without access to protocol |
| Other bias | Low risk | No other obvious sources of bias. A validated questionnaire was used for the primary outcome |