Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, infertility, hyperandrogenism, obesity, and insulin resistance. Myo-inositol is commonly used as an insulin-sensitizing agent to improve reproductive and metabolic outcomes in women with PCOS. Alpha-lactalbumin may enhance the intestinal absorption and bioavailability of myo-inositol and potentially improve treatment response.
This randomized controlled trial aims to compare the efficacy of myo-inositol alone versus myo-inositol plus alpha-lactalbumin in women with PCOS. Eighty-two eligible women will be randomized to receive either myo-inositol alone or myo-inositol combined with alpha-lactalbumin for 12 weeks. The study will evaluate reproductive outcomes including spontaneous conception, menstrual regularity, hirsutism, and hormonal parameters, as well as metabolic outcomes including body mass index and insulin resistance.
Female participants aged 18 to 35 years.
Diagnosed with polycystic ovary syndrome according to Rotterdam criteria.
Diagnosis of PCOS for at least 6 months before enrollment.
Willing to conceive.
Pre-existing diabetes mellitus.
Thyroid dysfunction.
Hyperprolactinemia.
Cushing syndrome.
Parallel
Myo-inositol
DrugMyo-inositol 2 g administered orally twice daily for 12 weeks. Participants receiving this intervention will also receive folic acid supplementation and standardized lifestyle and dietary counseling.
Alpha-Lactalbumin
Dietary supplementAlpha-lactalbumin 50 mg administered orally twice daily in combination with myo-inositol for 12 weeks. Participants receiving this intervention will also receive folic acid supplementation and standardized lifestyle and dietary counseling.
Spontaneous Conception Rate
Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test.
Achievement of Menstrual Regularity
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
Change in Modified Ferriman-Gallwey Score
Change in Modified Ferriman-Gallwey (mFG) score from baseline to week 12. The Modified Ferriman-Gallwey scale measures the degree of hirsutism and ranges from 0 to 36, with higher scores indicating greater severity of hirsutism and worse clinical status.
Change in Body Mass Index
Change in body mass index (kg/m²) from baseline to week 12.
Change in Serum Luteinizing Hormone Level
Change in serum luteinizing hormone concentration from baseline to week 12.
Change in LH/FSH Ratio
Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12.
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