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

Figures & data

Figure 1. Flow chart of the subjects included in the study.

Table 1. Patients’ characteristics at baseline.

	Study group (N = 30)			Control group (N = 30)
Quantitative patients’ characteristics at baseline
		95%CI			95%CI
	Mean (SD)	(LL, UL)	Mean (SD)		(LL, UL)
Age (years)	31.67 (0.86)	(29.91–33.42)	31.74 (0.89)		(29.91–33.57)
Weight (kg)	67.31 (2.33)	(62.53–72.09)	67.11 (2.09)		(62.82–71.4)
Height (cm)	162.67 (1.32)	(159.97–165.37)	164.11 (1.06)		(161.93–166.29)
BMI	25.51 (0.86)	(23.73–27.28)	24.88 (0.69)		(23.45–26.3)
Time of sterility (years)	3.35 (0.36)	(2.69–4)	2.57 (0.24)		(2.13–3.04)
Qualitative patients’ characteristics at baseline N (%)
Regular activity	10 (33.33%)		6 (20%)
Alcohol consumption	9 (30%)		6 (20%)
Smoking	7 (23.33%)		7 (23.33%)
No previous pregnancy	28 (93.33%)		23 (76.66%)
Familiar diabetes	7 (23.33%)		8 (26.66%)

p Values = not significant in all cases.

BMI: body mass index; CI: confidence interval; HL: high limit; LL: low limit.

Table 2. Summary results for reproductive and analytic outcomes.

		Study group					Control group
	95%CI						95%CI
	Mean (SD)		(LL–UL)			Mean (SD)		(LL–UL)		p Value
Number of oocytes	13.46 (1.01)		(11.38–15.54)			13.76 (1.48)		(10.67–16.85)		.864
No mature oocytes	3 (0.49)		(1.98–4.02)			3.1 (0.55)		(1.98–4.25)		.898
Mature oocytes	10.46 (0.88)		(8.65–12.28)			10.67 (1.57)		(7.4–13.94)		.910
Ratio mature oocytes/N. oocytes	0.77 (0.04)		(0.7–0.84)			0.74 (0.05)		(0.63–0.84)		.575
Number of embryos	6.88 (0.77)		(5.65–8.2)			7.19 (1.41)		(4.52–9.89)		.858
Embryos type A	3.08 (0.71)		(2–4.27)			3.86 (1.22)		(1.76–6.38)		.571
Embryos type B	1.5 (0.31)		(1–2.04)			1.35 (0.44)		(0.75–2.1)		.467
Embryos type C	1.81 (0.38)		(1.15–2.49)			1.6 (0.38)		(0.85–2.55)		.754
Insulin at baseline	11.75 (1.31)		(9.5–14.55)			11.53 (2.12)		(8.28–15.38)		.929
Insulin at end	9.04 (0.95)		(7.22–11.16)			9.05 (1.13)		(7.19–11.07)		.993
Difference in insulin	2.8 (1.04)		(1.15–4.83)			2.97 (2.19)		(−0.64–7.41)		.951
Testosterone at baseline	0.57 (0.04)		(0.48–0.66)			0.56 (0.05)		(0.45–0.67)		.911
Testosterone at end	0.41 (0.04)		(0.34–0.49)			0.46 (0.05)		(0.36–0.56)		.430
Difference of testosterone	0.14 (0.03)		(0.07–0.21)			0.12 (0.03)		(0.05–0.18)		.607
Glucose at baseline	90.82 (1.77)		(87.2–94.43)			91.85 (2.48)		(87.81–96.88)		.757
Glucose at the end	85.96 (1.1)		(83.7–88.22)			86.62 (1.51)		(83.49–89.76)		.720
Difference in glucose	4.61 (1.96)		(0.59–8.64)			5.77 (2.55)		(1.58–11.28)		.727
HOMA at baseline	2.64 (1.66)		(2.02–3.26)			2.65 (2.6)		(1.62–3.69)		.288
HOMA at the end	1.94 (1.1)		(1.51–2.37)			1.96 (1.23)		(1.43–2.49)		.719
Difference in HOMA	0.72 (1.31)		(0.21–1.24)			0.82 (2.52)		(−0.27–1.91)		.408

CI: confidence interval; LL: low limit; HL: high limit; HOMA: homeostasis medical assessment.

Table 3. Pregnancy outcomes.

	Number of cases per treatment group
		SG	CG	Risk ratio	95%CI		OR(A/B)	95%CI		p Value
					Lower limit	Upper limit		Lower limit	Upper limit
Pregancy rate	No	10	20	0.40	0.20	0.79	5.25	1.51	20.33	.003
	Yes	19	7
Miscarriage rate	No	16	4	2.71	0.71	10.42	0.27	0.02	2.76	.146
	Yes	3	3
Clinical pregnancy rate	No	10	20	0.40	0.20	0.79	5.25	1.51	20.33	.003
	Yes	19	7
Ongoing pregnancy rate	No	13	23	0.27	0.10	0.70	6.81	1.72	34.12	.002
	Yes	16	4
Pregnancy rate by stimulation cycle	No	9	18	0.40	0.19	0.84	5.44	1.38	24.35	.005
	Yes	17	6
Pregnancy by embryo transfer	No	8	13	0.46	0.23	0.95	4.43	1.09	20.30	.017
	Yes	17	6
Pregnancy per ITT analysis^a	No	14	23	0.38	0.17	0.82	4.65	1.48	14.61	.007
	Yes	17	6
Live-birth rate	No	13	23	0.27	0.10	0.70	6.81	1.72	34.12	.002
	Yes	16	4

SG: study group; CG: control group; CI: confidence interval; OR: odds ratio.

^aFor the ITT analysis the 60 women sample size were used, for the posterior exclusions, dropouts, canceled and spontaneous pregnancies, the worst result, no-occurrence, was assumed.