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

Официальное название

Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Пищевая добавка 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.

Первичные конечные точки

• Spontaneous Conception Rate [Срок оценки: 12 weeks]
• Achievement of Menstrual Regularity [Срок оценки: 12 weeks]

Вторичные конечные точки (9)

• Change in Modified Ferriman-Gallwey Score [Срок оценки: Baseline and 12 weeks]
• Change in Body Mass Index [Срок оценки: Baseline and 12 weeks]
• Change in Serum Luteinizing Hormone Level [Срок оценки: Baseline and 12 weeks]
• Change in LH/FSH Ratio [Срок оценки: Baseline and 12 weeks]
• Change in Fasting Glucose [Срок оценки: Baseline and 12 weeks]
• Change in Fasting Insulin [Срок оценки: Baseline and 12 weeks]
• Change in HOMA-IR [Срок оценки: Baseline and 12 weeks]
• Treatment Adherence [Срок оценки: 12 weeks]
• Incidence of Adverse Events [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College — Chak Four Hundred Fifty-four

Публикации

• 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

Идентификаторы

NCT: NCT07629895 · OBG-2025-033-14500 · 509/DME/QAMC Bahawalpur

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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