Stener‐Victorin 2003.
| Methods | Randomised, controlled multi‐centre trial in Sweden | |
| Participants | Women were randomised to either electro‐acupuncture and a paracervical block or alfentanil and a paracervical block, as analgesia at the time of oocyte retrieval. The mean age (range) in the study group was 32.9 years (22 to 38) and for the control group it was 32.9 years (25 to 38). The causes of infertility and number of IVF attempts did not differ between the two groups. |
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| Interventions | Women were given EA and a PCB of lidocaine hydrochloride during oocyte aspiration. Those women randomised to the alfentanil group were given alfentanil and a PCB during oocyte aspiration. The acupuncture stimulation began at least 30 min before oocyte aspiration | |
| Outcomes | VAS were used for pain assessment Other variables recorded included abdominal pain, pain during placement of PCB, time of discomfort, adequacy of analgesia, stress level, nausea. IVF outcomes were pregnancy rate (number of pregnancies per embryo transfer), implantation rate (number of gestational sacs per number of transferred oocytes) and on‐going pregnancies (number of pregnancies per embryo transfer after the 16th week of gestation) |
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| Assisted conception protocols | Protocol breakdown not provided | |
| Notes | Stopped after interim analysis as results show no difference between two groups. Study designed to assess effectiveness of acupuncture as an analgesic | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | not stated |
| Allocation concealment (selection bias) | Unclear risk | ‘sealed unlabeled envelopes’ |
| Blinding (performance bias and detection bias) All outcomes | High risk | Control group had paracervical block + Alfentanil and therefore blinding nor possible for clinicians or participants. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 286 randomized; 5 in the acupuncture group and 7 in the control group dropped out. |
| Selective reporting (reporting bias) | Unclear risk | Not known whether LBR a prestated outcome |
| Other bias | Low risk | None |