Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome
MIALA-PCOS
Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome
2 other identifiers
interventional
82
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 1, 2027
June 9, 2026
June 1, 2026
7 months
June 1, 2026
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Spontaneous Conception Rate
Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test.
12 weeks
Achievement of Menstrual Regularity
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
12 weeks
Secondary Outcomes (9)
Change in Modified Ferriman-Gallwey Score
Baseline and 12 weeks
Change in Body Mass Index
Baseline and 12 weeks
Change in Serum Luteinizing Hormone Level
Baseline and 12 weeks
Change in LH/FSH Ratio
Baseline and 12 weeks
Change in Fasting Glucose
Baseline and 12 weeks
- +4 more secondary outcomes
Study Arms (2)
Myo-Inositol Alone
ACTIVE COMPARATORParticipants will receive myo-inositol 2 g orally twice daily plus folic acid 400 micrograms daily for 12 weeks. Standardized lifestyle and dietary counseling will be provided.
Myo-Inositol Plus Alpha-Lactalbumin
EXPERIMENTALParticipants will receive myo-inositol 2 g plus alpha-lactalbumin 50 mg orally twice daily and folic acid 400 micrograms daily for 12 weeks. Standardized lifestyle and dietary counseling will be provided.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Normal husband semen analysis.
You may not qualify if:
- Pre-existing diabetes mellitus.
- Thyroid dysfunction.
- Hyperprolactinemia.
- Cushing syndrome.
- Congenital adrenal hyperplasia.
- Androgen-secreting adrenal or ovarian tumors.
- Conditions causing ovulatory dysfunction and/or hyperandrogenism other than PCOS.
- Use of ovulation-induction agents, hormonal therapy, insulin sensitizers, or anti-androgens within the previous 12 weeks.
- Morbid obesity (BMI ≥40 kg/m²).
- Known cow milk protein allergy, hypersensitivity to study medications, or severe gastrointestinal malabsorption.
- Hepatic, renal, or cardiovascular impairment.
- Tubal factor infertility.
- Endometriosis.
- Structural uterine abnormality.
- Male factor infertility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College
Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan
Related Publications (3)
Fitz V, Graca S, Mahalingaiah S, Liu J, Lai L, Butt A, Armour M, Rao V, Naidoo D, Maunder A, Yang G, Vaddiparthi V, Witchel SF, Pena A, Spritzer PM, Li R, Tay C, Mousa A, Teede H, Ee C. Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines. J Clin Endocrinol Metab. 2024 May 17;109(6):1630-1655. doi: 10.1210/clinem/dgad762.
PMID: 38163998RESULTTeede HJ, Tay CT, Laven JJE, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, Redman LM, Boyle JA, Norman RJ, Mousa A, Joham AE. Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2447-2469. doi: 10.1210/clinem/dgad463.
PMID: 37580314RESULTKamenov Z, Gateva A, Dinicola S, Unfer V. Comparing the Efficacy of Myo-Inositol Plus alpha-Lactalbumin vs. Myo-Inositol Alone on Reproductive and Metabolic Disturbances of Polycystic Ovary Syndrome. Metabolites. 2023 May 31;13(6):717. doi: 10.3390/metabo13060717.
PMID: 37367875RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Saba Nadeem, FCPS
Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 5, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be publicly shared because the study is an investigator-initiated academic dissertation study. Participant confidentiality and privacy will be maintained in accordance with institutional ethical requirements. Aggregate study findings may be published in scientific journals and presented at scientific meetings.