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. 2018 May 15;2018(5):CD004829. doi: 10.1002/14651858.CD004829.pub4

Humaidan 2004.

Methods Randomisation: computer‐generated
Allocation concealment: sealed unlabelled envelopes
Blinding of participants/investigators: no
Blinding of assessors: no
No. randomised: 200
No. analysed: 200
Intention‐to‐treat analysis: yes
Power and sample calculations described
Duration of trial: 9 months, from April to December 2002
Participants Women in IVF programme undergoing transvaginal oocyte retrieval
Mean age: 31 to 32 years (range 22 to 39)
Cause of infertility: male, tubal disease, endometriosis, anovulation, unexplained
Similar demographic and infertility characteristics at baseline
Interventions
  1. Control: conscious sedation and analgesia (with IV alfentanil 0.25 mg) and paracervical block (lidocaine 10 mL (5 mg/mL)) (N = 100)

  2. Intervention: electro‐acupuncture (EA) plus paracervical block (PCB) (N = 100)


Conscious sedation and analgesia group received premedication (oral benzodiazepine 10 mg); EA group did not
Outcomes
  1. Primary: intraoperative and postoperative pain scores (VAS 0 to 100)

  2. Secondary: pregnancy rate


Other outcomes reported: no. of cycles, no. of embryos transferred, implantation rate
Notes Denmark
Single centre
Skiive Hospital
Funding: not stated
Definition of pregnancy not documented
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Low risk Adequate: sealed unlabelled envelopes
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Blinding not possible owing to the nature of the interventions
Blinding of assessors not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Low risk Comparable demographic and infertility characteristics at baseline