Randomized Double Blind Placebo-controlled Study to Evaluate the Role of M2-Tone as an Adjuvant Treatment in IUI Protocol by Assessing its Effects on Endometrial Morphology, Vasculature and Pregnancy Rate Using 3D Color Doppler in Female Infertility

Abstract

ABSTRACT Objective To compare the efficacy of M2-Tone, a phytopharmaceutical, and placebo as an adjuvant in IUI protocol in improving endometrial receptivity as assessed by endometrial morphology, vascularity and pregnancy outcome in female infertility using the 3D color Doppler technique. Design Double blind placebo controlled comparative trial. Setting Outpatient clinic of MTTBC (Malhotra Test Tube Baby Center), Agra in India. Patient(s) Fifty-five patients with infertility were recruited. Twenty-eight patients were administered tablet M2-Tone and twenty-seven patients were given placebo. Both drugs were given orally in the dose of 2 tablets twice a day for three months prior to the IUI procedure. Intervention(s) M2-Tone, placebo, clomiphene citrate, hCG, 3D Color Doppler, IUI. Main outcome measure(s) Endometrial thickness, endometrial lining, endometrial vascularity, sex steroids and pregnancy rates. Result(s) Out of total 55 patients only 50 patients completed the study. In M2-Tone group endometrial thickness increased to mean 8.65 mm from 4.6 mm at baseline (Day 2 of menstrual cycle) whereas in placebo group it rose to mean 6.89 mm from 4.8 mm at baseline. The decrease in the mean score of uterine artery blood flow impedance (Pulsatility index PI) was 1.13 in M2-Tone group and 0.72 in placebo group. The uterine score in the M2-Tone group increased significantly from 3.15 to 13.31 and from 3.16 to 10.08 in placebo group. There was corresponding increase in pregnancy rate in the M2-Tone group (30.77%) as compared to the placebo group (16.66%). Though there was slight increase in the serum estradiol and progesterone levels in M2-Tone group compared to the placebo group the difference was not statistically significant. Conclusion(s) M2-Tone has shown better endometrial thickness, endometrial layering and better color flow to zone 3 of the endometrium compared to placebo. M2-Tone as an adjuvant treatment in IUI protocol showed significant improvement in pregnancy rate. This beneficial effect of M2-Tone can be attributed to improvement in the endometrial vascularity and morphology in the subjects by its modulating action on the hormonal status.