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.

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 + 150 mg of DCI twice daily; the control group (CG) was administered 550 mg of MYO + 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) = 0.4; 95%CI (0.2, 0.79); p = .003 and RR = 0.27; 95%CI (0.10, 0.70); p = .002 respectively]. The risk of ovarian hyperstimulation syndrome (OHSS) was lower in the SG (3.44 vs. 18.5%, p = .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

Oral Administration to Nursing Women of Lactobacillus fermentum CECT5716 Prevents Lactational Mastitis Development: A Randomized Controlled Trial

Objective: The objective of this study is to evaluate the preventive effect of oral administration of Lactobacillus fermentum CECT5716 on mastitis incidence in lactating women.Methods: A randomized double-blinded controlled trial that included 625 women was conducted. Women who received preventive dose of antibiotic in the context of delivery were recruited 1-6 days after childbirth and randomly assigned to a group. Probiotic group received 1 capsule/day containing L. fermentum 3 x 10(9) CFU, control group received 1 placebo capsule/day containing maltodextrin. The intervention period was 16 weeks. The primary outcome of the study was the incidence of clinical mastitis defined as at least two out of the three breast symptoms (pain, redness, and lump) and at least one of fever or flu-like symptoms (shivering, hot sweats, or aches).Results: Two hundred ninety-one women completed 16 weeks of treatment. Sixteen women in the probiotic group developed mastitis versus 30 women in the control group (odds ratio = 0.531; p = 0.058). Incidence rate of mastitis in the probiotic group was significantly lower than that in the control group (IR = 0.130 in the probiotic group versus IR = 0.263 in the control group; p = 0.021). Therefore, the oral administration of L. fermentum CECT5716 during lactation decreased by 51% the incidence rate of clinical mastitis. Staphylococcus spp. load at the end of intervention was significantly lower in breast milk of women in the probiotic group than in breast milk of women in the control group (p = 0.025).Conclusion: Consumption of the probiotic strain L. fermentum CECT5716 might be used during breastfeeding as an efficient strategy to prevent development of lactational mastitis in women