Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorQuaid-e-Azam Medical College

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Pre-existing diabetes mellitus.

Thyroid dysfunction.

Hyperprolactinemia.

Cushing syndrome.

Trial design

Treatments tested in this trial

  • Myo-inositol
  • Alpha-Lactalbumin

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators