Shawki 2012.
Methods | RCT Single centre Egypt |
|
Participants | Included women undergoing ICSI cycle. Mixed group consisting of women
undergoing first ICSI, or after one, two, or more failures. All women
underwent HSG 2 to 3 months prior to IVF. Exclusion: Abnormal HSG Abnormal TVS Intrauterine surgery history Contraindication for hysteroscopy |
|
Interventions | Intervention group (N = 120): vaginoscopic approach hysteroscopy done. For
normal hysteroscopy findings, methylene blue injected to identify
endometrial pathology, such as endometrial hyperplasia or endometritis, and
biopsy taken. Abnormal hysteroscopy findings were recorded and treated. Control group (N = 120): no hysteroscopy |
|
Outcomes | Implantation rate, clinical pregnancy rate, normal and abnormal hysteroscopy findings | |
Notes | Authors were contacted for data, however, authors did not respond to emails. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Containing computer generated random numbers". |
Allocation concealment (selection bias) | Unclear risk | Authors mention 'sealed envelopes' containing random numbers. Authors did not describe actual allocation concealment, specifically did not mention consecutively numbered opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding was not mentioned. However, absence of blinding was unlikely to influence performance bias. Hence, absence of blinding was categorised as low risk for performance bias. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding was not mentioned. However, absence of blinding was unlikely to influence the findings for our primary and secondary outcomes, hence, categorised as low risk for detection bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants and losses to follow‐up were mentioned, and appeared to be balanced. However, intention‐to‐treat analysis not done. |
Selective reporting (reporting bias) | Unclear risk | The published protocol for this study was not available. While prespecified outcomes of interest were reported, primary outcome (live birth) was not reported. |
Other bias | Low risk | We found no other potential sources of within‐study bias. Source of funding was mentioned. |