Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myo-inositol, Alpha-Lactalbumin.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome (PCOS). Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome
Overview
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.
Detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age and is characterized by ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. Insulin resistance plays a central role in the pathophysiology of PCOS and contributes to reproductive and metabolic abnormalities. Consequently, insulin-sensitizing therapies are increasingly used to improve clinical outcomes.
Myo-inositol is an insulin-sensitizing agent that has demonstrated beneficial effects on ovulation, menstrual regularity, endocrine function, and metabolic parameters in women with PCOS. However, some patients demonstrate a suboptimal response to myo-inositol alone. Alpha-lactalbumin, a whey protein fraction, has been reported to enhance intestinal absorption and bioavailability of myo-inositol, potentially leading to improved therapeutic outcomes.
This study is a prospective randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Sadiq Abbasi Hospital, Quaid-e-Azam Medical College, Bahawalpur, Pakistan. A total of 82 women aged 18 to 35 years diagnosed with PCOS according to the Rotterdam criteria will be enrolled and randomized in a 1:1 ratio into two treatment groups.
Participants in Group A will receive myo-inositol 2 g orally twice daily with folic acid supplementation. Participants in Group B will receive myo-inositol 2 g plus alpha-lactalbumin 50 mg orally twice daily with folic acid supplementation. Both groups will receive standardized lifestyle and dietary counseling. The treatment duration will be 12 weeks.
The primary outcomes will be spontaneous conception and achievement of menstrual regularity at 12 weeks. Secondary outcomes will include changes in modified Ferriman-Gallwey score, serum luteinizing hormone levels, LH/FSH ratio, body mass index, fasting glucose, fasting insulin, and homeostatic model assessment of insulin resistance (HOMA-IR). Treatment adherence and adverse events will also be assessed.
The study aims to generate local evidence regarding the comparative effectiveness of myo-inositol alone versus myo-inositol combined with alpha-lactalbumin in improving reproductive and metabolic outcomes among women with 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.
Primary outcome measures
- Spontaneous Conception Rate [Time frame: 12 weeks]
- Achievement of Menstrual Regularity [Time frame: 12 weeks]
Secondary outcome measures (9)
- Change in Modified Ferriman-Gallwey Score [Time frame: Baseline and 12 weeks]
- Change in Body Mass Index [Time frame: Baseline and 12 weeks]
- Change in Serum Luteinizing Hormone Level [Time frame: Baseline and 12 weeks]
- Change in LH/FSH Ratio [Time frame: Baseline and 12 weeks]
- Change in Fasting Glucose [Time frame: Baseline and 12 weeks]
- Change in Fasting Insulin [Time frame: Baseline and 12 weeks]
- Change in HOMA-IR [Time frame: Baseline and 12 weeks]
- Treatment Adherence [Time frame: 12 weeks]
- Incidence of Adverse Events [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College — Chak Four Hundred Fifty-four
Publications
- 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. do PMID 38163998
- Teede 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 37580314
- Kamenov 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 37367875
Identifiers
NCT: NCT07629895 · OBG-2025-033-14500 · 509/DME/QAMC Bahawalpur