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

NCT07629895 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-06-09

No results posted yet for this study

Summary

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.

Conditions

  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

Myo-inositol

Myo-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.

DIETARY_SUPPLEMENT

Alpha-Lactalbumin

Alpha-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.

Sponsors & Collaborators

  • Quaid-e-Azam Medical College

    lead OTHER

Principal Investigators

  • Saba Nadeem, FCPS · Sadiq Abbasi Hospital/Quaid-e-Azam Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-04-30
Completion
2027-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07629895 on ClinicalTrials.gov