CompletedNot Applicable

Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

Italy50 participantsStarted 2012-01

Plain-language summary

Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.

Who can participate

Age range18 Years – 35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003 * BMI \> 25 kg/m2 * age 18-35 years Exclusion Criteria: * pregnancy * significant liver or renal impairment * other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs) * neoplasms * unstable mental illness * diagnosis of diabetes mellitus or impaired glucose tolerance * use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.

What they're measuring

number of cycles in six months of therapy

Timeframe: 6 months

Trial details

NCT IDNCT01555190

SponsorCatholic University of the Sacred Heart

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

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