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. 2018 Dec 5;2018(12):CD009461. doi: 10.1002/14651858.CD009461.pub4

Summary of findings for the main comparison. Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities.

Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities
Patient or population: women with submucous fibroids and otherwise unexplained subfertility
Settings: infertility centre in Rome, Italy
Intervention: hysteroscopic removal of 1 submucous fibroid ≤ 40 mm
Comparison: no surgery
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of participants
 (studies) Quality of the evidence
 (GRADE) Comments
Assumed risk Corresponding risk
No surgery Myomectomy
Live birth No data reported.
Adverse events: hysteroscopy complications No data reported.
Clinical pregnancya
Ultrasound
12 months
214 per 1000 400 per 1000
 (209 to 627) OR 2.44
(0.97 to 6.17)
94
 (1 study) ⊕⊝⊝⊝
 Very lowb,c
Adverse events: miscarriaged
Ultrasound
12 months
119 per 1000 172 per 1000
 (63 to 477) OR 1.54
(0.47 to 5.00)
94 women
 (1 study) ⊕⊝⊝⊝
 Very lowb,c
*The basis for the assumed risk is the control group risk of the single included study (Casini 2006). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 CI: confidence interval; OR: odds ratio.
GRADE Working Group grades of evidence
 High quality: further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: we are very uncertain about the estimate.

aClinical pregnancy defined by the visualisation of an embryo with cardiac activity at six to seven weeks' gestational age.

bDowngraded by two levels for very serious risk of bias (unclear allocation concealment, high risk of selective outcome reporting and unclear whether there is other bias caused by imbalance in the baseline characteristics).

cDowngraded by one level for serious imprecision (wide confidence interval of the effect size estimate).

dMiscarriage was defined by the clinical loss of an intrauterine pregnancy between the 7th and 12th weeks of gestation.