Table 1.
Characteristics of the included RCTs
| Authors (Publication year) | Diagnosis criteria (Country) | Interventionduration | Interventions (Sample size) | Lifestyle intervention | Trial group (Age;baseline BMI) | Control group (Age;baseline BMI) | Outcomes |
|---|---|---|---|---|---|---|---|
| Mojca Jensterle [37] (2015) | NICHD (Slovenia) | 12wk |
LIRA 1.2 mg QD (n = 17) vs MET 1000 mg BID (n = 15) |
Not actively promoted |
29.5 ± 7.7(y); 40.8 ± 6.1 kg/m2 |
25.3 ± 5.2(y); 38.2 ± 7 kg/m2 |
MF, weight, metabolic, endocrine changes, TBF |
| Karen Elkind-Hirsch [25] (2008) | Rotterdam (Louisiana) | 24wk |
COMBI (EXE 10 μg BID + MET 1000 mg BID) (n = 20) vs EXE 10 μg BID (n = 20) vs MET 1000 mg BID (n = 20) |
On unrestricted diet |
COMBI: 32.1 ± 0.7(y); 41.2 ± 1.7 kg/m2 EXE:28.2 ± 1.1(y); 39.9 ± 1.5 kg/m2 |
27.7 ± 1.3(y); 41.3 ± 1.8 kg/m2 |
MF, ovulation rate, insulin action, anthropometric measures, androgen levels, inflammatory markers |
| Renyuan Li [26] (2022) | Rotterdam (China) | 12wk |
EXE 5–10 μg BID (n = 80)*12wk + MET 1000 mg BID*52wk vs MET 1000 mg BID (n = 80)*12wk + MET 1000 mg BID*52wk |
Actively promoted |
28.19 ± 3.96(y); 29.07 ± 3.92 kg/m2 |
27.83 ± 3.52(y); 29.15 ± 4.11 kg/m2 |
Spontaneous and total PR, pregnancy outcomes, metabolic parameters |
| Juan Wang [27] (2017) | Rotterdam (China) | 3 month |
EXE 10 μg BID (n = 45) vs MET 500–2000 mg daily (n = 33) |
NM |
25.92 ± 6.75(y); 26.26 ± 5.71 kg/m2 |
25.67 ± 7.33(y); 25.74 ± 6.37 kg/m2 |
PR, sex hormone, ovulation rate, glucose metabolic index, AngII/Ang(1–7) |
| Malin Nylander [28] (2017) | Rotterdam (Denmark) | 26wk |
LIRA 1.8 mg QD (n = 48) vs Placebo 1.8 mg QD (n = 24) |
NM |
31.4(24.6–35.6)(y); 33.3 ± 5.1 kg/m2 |
26.2(24.8–31.5)(y); 33.3 ± 4.6 kg/m2 |
MF, ovarian and stromal volume, antral follicle count, sex hormone |
| Xin Liu [38] (2017) | Rotterdam (China) | 12wk |
EXE 10 μg BID*12wk + MET*12wk (n = 88) vs MET 1000 mg BID*12wk + MET*12wk (n = 88) |
Promoted |
27.93 ± 2.70(y); 29.16 ± 3.11 kg/m2 |
27.69 ± 3.80(y); 28.29 ± 1.86 kg/m2 |
Natural PR, MF, weight, BMI, TBF, metabolic and endocrine changes, inflammatory markers |
| Karen E. Elkind-Hirsch [39] (2022) | NIH (Louisiana) | 32wk |
LIRA 3 mg QD (n = 55) vs Placebo 3 mg QD (n = 27) |
Promoted |
31 ± 0.8(y); 41.6 ± 0.9 kg/m2 |
32 ± 1.1(y); 43.9 ± 1.5 kg/m2 |
MF, weight and FAI, waist circumference, BMI, sex hormone, OGTT result, insulin action, lipids profile, BP, TBF |
| Vesna Salamun [40] (2018) | Rotterdam (Slovenija) | 12wk |
COMBI (LIRA 1.2 mg QD + MET 1000 mg BID) (n = 14) vs MET 1000 mg BID (n = 14) |
Actively promoted |
30.1 ± 3.6(y); 37.8 ± 3.0 kg/m2 |
31.1 ± 4.7(y); 35.5 ± 4.9 kg/m2 |
Cumulative PR(IVF and spontaneous); oocyte and embryo quality, weight, metabolic and endocrine parameters, TBF |
| Siyuan Zheng [41] (2017) | Rotterdam (China) | 12wk |
EXE 10 μg BID (n = 41) vs MET 1000 mg BID (n = 41) |
Promoted |
27.7 ± 3.41(y); 29.18 ± 4.15 kg/m2 |
28.16 ± 3.92(y); 29 ± 4.1 kg/m2 |
MF, weight, hirsutism, metabolic and endocrine change, inflammatory marker levels |
| Mojca Jensterle [42] (2014) | NICHD (Slovenia) | 12wk |
LIRA 1.2 mg QD (n = 15) vs MET 1000 mg BID (n = 15) |
Promoted |
30.7 ± 7.9(y)a; 36.7 ± 5.6 kg/m2 |
30.7 ± 7.9(y)a; 39.4 ± 6.9 kg/m2 |
MF, weight, metabolic and endocrine change |
| Mojca Jensterle Sever [35] (2014) | NICHD (Slovenia) | 12wk |
COMBI (LIRA 1.2 mg QD + MET 1000 mg BID) (n = 13) vs LIRA 1.2 mg QD (n = 13) vs MET 1000 mg BID (n = 14) |
Not actively promoted |
COMBI:31.1 ± 5.1(y); 37.6 ± 5.1 kg/m2 LIRA:31.5 ± 6.4(y); 39.3 ± 4.2 kg/m2 |
31.3 ± 9.4(y); 36.6 ± 3.5 kg/m2 |
MF, weight, metabolic and endocrine change, TBF |
aAge were not given separately