Dieterle 2006.
Methods | Randomised controlled trial, fertility patients in clinic in Germany | |
Participants | 225 patients randomised: 116 to treatment and 109 to placebo. Treatment included placing Chinese herbs in patients' ears. No losses to follow up. Placebo treatment at sites that will not affect fertility, but physicians who were performing ET were blinded. The average age (± SD) of the study group (n = 116) was 35.1 years (± 3.8) compared to 34.7 years (± 4) for the placebo group (n = 109). There were no statistical differences in the body mass index (BMI), causes of subfertility, and number of previous cycles between the study and control groups. |
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Interventions | Treatment included acupuncture + Chinese herbs in ears versus control group of acupuncture at sites that are not believed to affect fertility. The intervention was performed for 30 minutes after embryo transfer and again 3 days later. All acupuncture was performed by the same practitioner | |
Outcomes | Live birth rate, clinical pregnancy rates and ongoing clinical pregnancy rates | |
Assisted conception protocols | Standard, long protocol GnRH down‐regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG) | |
Notes | Placebo group did not have drugs placed in ears | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated in the manuscript |
Allocation concealment (selection bias) | Unclear risk | ‘randomised with sealed randomization envelopes’ but not stated if these envelopes where opaque or sequentially numbered. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Use of placebo treatment in control group |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 225 participants randomized; none lost to follow up. |
Selective reporting (reporting bias) | Unclear risk | Not known whether LBR a prestated outcome |
Other bias | Low risk | None known |