← Metformin × pregnancy & neonatal

SynthesisThe Cochrane database of systematic reviews2012

Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility.

Thomas Tang et al.PubMed ↗Publisher ↗

  • Metforminlooks bad hereHigher clinical pregnancy rates, higher gastrointestinal disturbances.Randomised, large.
  • Metformin and clomiphenelooks bad hereHigher clinical pregnancy rates.Randomised, large.
  • Clomiphene alonelooks good hereLower live birth rate, lower clinical pregnancy rate.Weak evidence: one subgroup.
  • Metformin aloneno clear effectNo clear effect on live birth rates.Nothing cleared the noise.

What the trial testedrandomised · 3,992 people · 2012

Randomised vs placebo

Raised clinical pregnancy rates

2.3×1.5× to 3.5×

metformin vs placebo

Bigger than 9 in 10 on the map

As reported

OR 2.31, 95% CI 1.52–3.51

Randomised vs clomiphene alone

Raised clinical pregnancy rates

+51%+17% to +96%

metformin and clomiphene vs clomiphene alone

Bigger than 7 in 10 on the map

As reported

OR 1.51, 95% CI 1.17–1.96

Randomised vs placebo

Raised gastrointestinal disturbances

4.3×2.4× to 7.6×

metformin vs placebo

Bigger than 9 in 10 for adverse events & safety

As reported

OR 4.27, 95% CI 2.40–7.59 · the paper's word: incidence of gastrointestinal disturbances

One subgroup

May have lowered live birth rate in obese women

−70%−83% to −48%

clomiphene alone vs metformin and clomiphene, in obese women

Bigger than 9 in 10 on the map

As reported

OR 0.3, 95% CI 0.17–0.52

+3 more in the walkthrough ↓

Who was studied, and how

3,992people with gestational diabetes, in this paper

The trial randomly assignedassigned by chance

metformin alone
placebo or no treatment (implied by context of 'used alone' vs control)

No clear effect on live birth rates1.8×

randomised

The trial randomly assignedassigned by chance

metformin in combination with clomiphene
clomiphene alone (implied by context)

No clear effect on live birth rates+16%

randomised

the abstract, start to end

… whether it was used alone (pooled OR 1.80, 95% CI 0.52 to 6.16, 3 trials, 115 women) or in combination with clomiphene (pooled OR 1.16, 95% CI 0.85 to 1.56, 7 trials, …

… for metformin versus placebo (pooled OR 2.31, 95% CI 1.52 to 3.51, 8 trials, 707 women) and for metformin and clomiphene versus clomiphene alone (pooled OR 1.51, 95% CI 1.17 to 1.96, 11 …

… an improved live birth rate (pooled OR 0.3, 95% CI 0.17 to 0.52, 2 trials, 500 women) and clinical pregnancy rate (pooled OR 0.34, 95% 0.21 to 0.55, 2 trials, 500 women) in the group of obese women who took clomiphene.Metformin was also associated with a significantly higher incidence of gastrointestinal disturbances than placebo (pooled OR 4.27, 95% CI 2.4 to 7.59, 5 trials, …

← favours treatmentfavours comparator →
could be chance
Live birth ratesmetformin alone vs placebo or no treatment (implied by context of 'used alone' vs control)
OR 1.800.52–6.16
Live birth ratesmetformin in combination with clomiphene vs clomiphene alone (implied by context)
OR 1.160.85–1.56
Clinical pregnancy ratesmetformin vs placebo
OR 2.311.52–3.51
Clinical pregnancy ratesmetformin and clomiphene vs clomiphene alone
OR 1.511.17–1.96
Live birth rateclomiphene alone vs metformin and clomiphene, in obese women
OR 0.30.17–0.52
Clinical pregnancy rateclomiphene alone vs metformin and clomiphene, in obese women
OR 0.340.21–0.55
Incidence of gastrointestinal disturbancesmetformin vs placebo
OR 4.272.40–7.59
MetforminPregnancy & neonatalAdverse events & safety

Metformin × pregnancy & neonatalhelps?mixed

unlikelylikely
0.00not counted

Metformin × adverse events & safetyharms?mixed

unlikelylikely
0.27not counted
← favours treatmentfavours comparator →
more certainless certain
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114 papers cite itlatest 60 shown

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The trial

NCT0488185176 enrolled2015
Full record →Abstract, authors, funding and every citing paper · PMID 22592687