Comparison of the effect of two combinations of myo-inositol and D -chiro-inositol in women with polycystic ovary syndrome undergoing ICSI: a randomized controlled trial

Abstract

The purpose of this study was to evaluate the effect of two doses of D-chiro-inositol (DCI) in combination with Myo-inositol (MYO) in women with PCOS undergoing ICSI. This was a multicenter controlled, randomized, double-blind parallel group study with two MYO-DCI formulations for 12 weeks. The study group (SG) was administered 550 mg of MYO þ 150 mg of DCI twice daily; the control group (CG) was administered 550 mg of MYO þ 13.8 mg of DCI twice daily. The participants comprised 60 women with PCOS undergoing ICSI. At baseline, no differences were found between the two groups regarding age, BMI, HOMA-IR or testosterone levels. The pregnancy and live birth rates were significantly higher in the SG than in the CG (65.5 vs. 25.9 and 55.2 vs. 14.8, respectively) [risk ratio (RR) ¼ 0.4; 95%CI (0.2, 0.79); p ¼ .003 and RR ¼ 0.27; 95%CI (0.10, 0.70); p ¼ .002 respectively]. The risk of ovarian hyperstimulation syndrome (OHSS) was lower in the SG (3.44 vs. 18.5%, p ¼ .07). The combination of MYO-DCI at high doses of DCI improves the pregnancy rates and reduces the risk of OHSS in women with PCOS undergoing ICSI.

Inositols: From Established Knowledge to Novel Approaches

“…Although other ratios were analyzed, these combinations were without a scientific rationale [ 51 ]; conversely the 40:1 ratio that may appear arbitrary, actually is similar to the plasma ratio reported in healthy women [ 51 , 52 , 53 , 54 ], thus supporting its supplementation to restore the physiological concentrations of myo-Ins and D-chiro-Ins. On the other hand, one study [ 55 ] considers the amount of DCI in the 40:1 ratio very low and proposes combining the two inositols using D-chiro-Ins at high doses. However, some concerns arise when D-chiro-Ins is used at high doses and for prolonged time, as demonstrated in a recent paper by Bevilacqua et al [ 56 ] and discussed below.…”

Impact of myo-inositol treatment in women with polycystic ovary syndrome in assisted reproductive technologies

“…On the contrary, three meta-analyses failed to conclude on the effect of MI in women with PCOS [14,21,22]. Mendoza [14] reported, in 8 studies involving 1019 PCOS women, a not significant trend towards improvement in egg quality (OR: 2.2; 95% CI 0.8-5.8), embryo quality (OR 1.6; 95% CI 0.3-6.7) and pregnancy rate (OR: 1.2; 95% CI 0.8-1.8) with MI administration.…”

“…He concluded that future studies of dose, size and duration of DCI are necessary. Since, two other controlled, randomized, double blind parallel group studies of the same author [21,22] showed (after 12 weeks of treatment in women with PCOS undergoing ICSI), (i) a significant increase of pregnancy and live birth rates (65.5 vs. 25.9; p: 0.003, and 55.2 vs. 14.8; p: 0.002, respectively) and a decrease of ovarian hyperstimulation syndrome (3.4 vs. 18.5%; p: 0.07) with a 3.6:1 MI/DCI ratio compared to a 40:1 ratio [21]; (ii) a positive influence (p: 0.006) on the quality of the cytoplasm of the oocyte with a 1.8:1 ratio compared to a 20:1 ratio [22]. So, the debate on the appropriate MI/DCI ratio remains unresolved.…”

The comparative effectiveness of 55 interventions in obese patients with polycystic ovary syndrome: A network meta-analysis of 101 randomized trials

“…Following title and abstract screening, 408 full-text articles were retrieved and screened for eligibility. Of them, 307 articles were excluded, and 101 RCTs [20-32, 33, 34-43, 44, 45- [121][122][123][124][125][126][127][128][129][130][131][132][133][134][135][136], however, they could not be added to our analysis due to the following causes: five studies failed to meet our BMI criteria , three studies included irrelevant interventions [133][134][135], two studies had an open-label design [127,128], two studies measured different outcomes [131,132], one study had a cost-effectiveness design [121], one study had a post-hoc design [129], one study had no treatment control [122], and one study included pregnant patients [130]. Additionally, the bibliography of the included RCTs was manually searched, but no further records were added.…”