Management of women with PCOS using myo-inositol and folic acid. New clinical data and review of the literature

Abstract

Introduction The use of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day is a safe and promising tool in the effective improvement of symptoms and infertility for patients with polycystic ovary syndrome (PCOS). In addition, PCOS is one of the pathological factors involved in the failure of in vitro fertilization (IVF). Typically, PCOS patients suffer of poor quality oocytes. Patients and methods In an open, prospective, non-blinded, non-comparative observational study, 3602 infertile women used myo-inositol and folic acid between 2 and 3 months in a dosage of 2 × 2000 mg myo-inositol +2 × 200 μg folic acid per day. In a subgroup of 32 patients, hormonal values for testosterone, free testosterone and progesterone were analyzed before and after 12 weeks of treatment. The mean time of use was 10.2 weeks. In the second part of this trial it was investigated if the combination of myo-inositol + folic acid was able to improve the oocyte quality, the ratio between follicles and retrieved oocytes, the fertilization rate and the embryo quality in PCOS patients undergoing IVF treatments. Twenty-nine patients with PCOS, underwent IVF protocols for infertility treatment and were randomized prospectively into two groups. Group A (placebo) with 15 patients and group B (4000 mg myo-inositol +400 μg folic acid per day) with 14 patients were evaluated. The patients of group B used 2 months' myo-inositol + folic acid before starting the IVF protocol. For statistically analyses Student's t-test was performed. Results Seventy percent of the women had a restored ovulation, and 545 pregnancies were observed. This means a pregnancy rate of 15.1% of all the myo-inositol and folic acid users. In 19 cases a concomitant medication with clomiphene or dexamethasone was used. One twin pregnancy was documented. Testosterone levels changed from 96.6 ng/mL to 43.3 ng/mL and progesterone from 2.1 ng/mL to 12.3 ng/mL in the mean after 12 weeks of treatment (p < 0.05) Student's t-test. No relevant side effects were present among the patients. The women in the IVF treatment the group A showed a higher number of retrieved oocytes than group B. Nevertheless, the ratio follicle/retrieved oocyte was clearly better in the myo-inositol group (= group B). Out of the 233 oocytes collected in the myo-inositol group, 136 where fertilized whereas only 128 out of 300 oocytes were fertilized in the placebo group. With regards to the oocytes quality, better data were obtained in the myo-inositol group. More metaphase II and I oocytes were retrieved in relation to the total number of oocytes, when compared with the placebo group. Also, more embryos of grade I quality were observed in the myo-inositol group than in the placebo group. The duration of stimulation was 9.7 days (±3.3) in the myo-inositol group and 11.2 (±1.8) days in the placebo group and the number of used follicle-stimulating hormone (FSH) units was lower in the myo-inositol group in comparison to the placebo group: 1850 FSH units (mean) versus 1850 units (mean). Discussion Myo-inositol has pr...

Efficacy and Safety of Tracnil™ Administration in Patients with Dermatological Manifestations of PCOS: An Open-Label Single-Arm Study

“…While at the time of enrollment, menstrual irregularity was observed in 70% of the subjects, and it Dermatology Research and Practice markedly dropped to 3% by the end of the study period. Regidor et al has observed similar results with myo-inositol and folic acid administration on German women [11]. A nonhormonal preparation with such a potential to regularize menstrual cycle in these women is of great significance.…”

“…A newer nonhormonal alternative for PCOS is myoinositol, a common stereoisomer of inositol, abundant in plants and animal tissues [7,8]. Myo-inositol administration has been widely shown to modulate hormonal fluctuations and improve fertility in patients with PCOS, by correcting insulin resistance [9][10][11]. Inositol helps improve skin condition by reducing hyperandrogenism [12] or many other closely related mechanisms of action.…”

Mechanisms of Insulin Resistance Formation in Polycystic Ovarian Disease and Therapeutic Effects from Myo Inositol

“…Полученные данные подтвердили гипотезу о том, что снижение уровня инсулина, вызванное MИ, основано на повышении биодоступности вторичного мессенджера инсулина IPG. Следовательно, для нормализации функционирования эндокринной системы необходимо улучшение внутриклеточного обмена [50]. Механизм влияния МИ на снижение уровней андрогенов в приведенных исследованиях авторы объясняют тем, что сигнальные пути IPG вовлечены в инсулин-опосредованный биосинтез андрогенов тека-клетками, поэтому дефицит МИ и нарушенная конверсия МИ в ДХИ при СПКЯ способствуют гиперандрогении.…”

“…Это иссле-дование открыло новую страницу в понимании механизмов действия инозитола. В дальнейшем последовал ряд исследований, доказывающих прямую корреляцию между уровнем МИ в ФЖ, качеством ооцитов и исходом беременности [34,45,47,50,52,53]. Р.А.…”

“…Более того, в группе женщин, получавших МИ, количество дней стимуляции было меньше (9,7 дня в сравнении с 11,2). Это, вероятно, связано с более быстрой реакцией на стимуляцию ФСГ [50].…”