Dal Prato 2009.
| Methods | Study type: randomised study Country: Italy Setting: women attending IVF/ICSI clinic Duration of recruitment: June 2005 to June 2007 Duration of trial: 2 years Follow‐up: clinical pregnancy at least 4 weeks after embryo transfer |
|
| Participants | Inclusion: age < 44 years; regular ovulatory menstrual cycles of 25 to 33 days; infertility due to tubal, idopathic or male factors, or endometriosis, no more than 2 previous embryo transfers Exclusion: FSH concentration > 15 IU/l on day 3 of the menstrual cycle; those who previously showed poor response to gonadotrophins #Randomised: n = 200 Baseline characteristics: all women; age 28 to 43 years; causes of infertility included factors such as tubal (26.1% vs. 44%), male (36.1% vs. 42.1%), endometriosis (31.3% vs. 28.6%) or unexplained (45.5% vs. 35%), respectively for piroxicam vs control. |
|
| Interventions | Intervention: treatment group (n = 100) received single oral dose of 10 mg piroxicam 1 to 2 hours before embryo transfer vs. control (no treatment; n = 100) Co‐intervention: long luteal protocol |
|
| Outcomes | Primary outcomes: clinical pregnancy rate Secondary outcomes: the number of participants with a positive b‐HCG test, miscarriages, implantation rate |
|
| Notes | Ethics: informed consent; approved by Institutional Review Board Funding: not stated Sample size provided No adverse effects reported due to treatment; ectopic pregnancies were reported Protocol of the study not provided |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The randomisation list was provided by an external statistician |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, sealed, dark envelopes (opened by a nurse not involved in the trial) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding performed ("because it was not possible to provide a placebo", as authors stated) |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant was excluded from the final analysis. Primary outcomes of the review were addressed |
| Selective reporting (reporting bias) | Unclear risk | All data were reported and discussed according to the initially stated objectives of the study authors. No protocol provided |
| Other bias | Low risk | No apparent evidence of other bias |