To determine the pregnancy rates under the use of a combination of myoinositol and folic acid in patients with a PCOS in Germany, to establish if this molecule can be used as a safer treatment option for the fertility improvement of this disease.
A standardised questionnaire between June 2014 and March 2015
3602 women with PCOS and infertility
The women started with the intake of myoinositol and folic acid at a dosage of 2 × 2000 mg myoinositol and 2 × 200 μg folic acid per day and used it for at least 2-3 months.
Main outcome measures
The primary outcome of the study was to determine the ovulatory function restoration and the pregnancy rate after treatment. The pregnancies were documented by the gynaecologists and registered in a database, and these women were followed up during the whole pregnancy. Secondary outcome was the evaluation of side effects reported in those patients undergoing treatment. In a subgroup of patients, hormonal values were also evaluated. The values investigated were testosterone, free testosterone, and progesterone. In this group of patients the pregnancies outcome has also been checked.
The data of 3602 patients with PCOS syndrome were evaluated. According to the obtained records 2520 women experienced an improvement of their menstrual cyclicality towards ovulatory cycles. Among them, a total number of 545 women became pregnant.The pregnancies occurred after the intake of two to three months of myoinositol and folic acid. This means a ratio of 15.1% of the investigated women becomes pregnant during this observational study. No twin pregnancies were documented. No relevant side effects have been reported in the patients taking myoinositol and folic acid product.
In conclusion, myoinositol is not only an effective alternative in the treatment of PCOS patients but also a secure one as no side effects could be observed in the standard dosage. This is on the other side relevant as the compliance of the use rises resulting in better outcomes in the management of ovulation, hyperandrogegism, and metabolic parameters on patients with a PCOS.
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