Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women. (IROP-1)
Polycystic Ovarian Syndrome, Infertility, Female
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring Inositol, Polycystic ovarian syndrome, Fertility, Clinical pregnancy rate, Miscarriage rate, Live birth rate
Eligibility Criteria
Inclusion Criteria:
- Women with PCOS diagnosed by Rotterdam criteria in couple that desire to conceive.
Exclusion Criteria:
- Male infertility factor that require in vitro fertilization technique.
- Women with infertility factors that require in vitro fertilization technique.
- Couple with infertility factors that require in vitro fertilization technique.
- Diabetes mellitus that require insulin or oral drugs treatment.
- Any other pre-pregnancy or pregnancy-induced/related disease.
- Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Inositol + Folic acid
Folic acid
Couples with PCOS infertile women, diagnosed according to the Rotterdam criteria, who access infertility center with conception desire. These women will receive oral supplementation with Inositol (Myo-inositol and D-chiro-inositol at 40:1 ratio) plus Folic acid for 6 months. Couples are required to have regular intercourse with the aim to achieve a spontaneous conception.
Couples with PCOS infertile women, diagnosed according to the Rotterdam criteria, who access infertility center with conception desire. These women will receive oral supplementation with Folic acid for 6 months. Couples are required to have regular intercourse with the aim to achieve a spontaneous conception.