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
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.
Обзор исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Kaleem A Dr, FCPS
- Номер телефона: +92-302-4750515
- Электронная почта: sara.qmc@qamc.edu.pk
Места учебы
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Punjab Province
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Chak Four Hundred Fifty-four, Punjab Province, Пакистан, 63100
- Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Myo-Inositol Alone
Participants 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.
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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.
|
|
Экспериментальный: Myo-Inositol Plus Alpha-Lactalbumin
Participants 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Spontaneous Conception Rate
Временное ограничение: 12 weeks
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Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test.
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12 weeks
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Achievement of Menstrual Regularity
Временное ограничение: 12 weeks
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Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
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12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Body Mass Index
Временное ограничение: Baseline and 12 weeks
|
Change in body mass index (kg/m²) from baseline to week 12.
|
Baseline and 12 weeks
|
|
Change in Serum Luteinizing Hormone Level
Временное ограничение: Baseline and 12 weeks
|
Change in serum luteinizing hormone concentration from baseline to week 12.
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Baseline and 12 weeks
|
|
Change in LH/FSH Ratio
Временное ограничение: Baseline and 12 weeks
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Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12.
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Baseline and 12 weeks
|
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Change in Fasting Glucose
Временное ограничение: Baseline and 12 weeks
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Change in fasting glucose level from baseline to week 12.
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Baseline and 12 weeks
|
|
Change in Fasting Insulin
Временное ограничение: Baseline and 12 weeks
|
Change in fasting insulin level from baseline to week 12.
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Baseline and 12 weeks
|
|
Change in HOMA-IR
Временное ограничение: Baseline and 12 weeks
|
Change in insulin resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
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Baseline and 12 weeks
|
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Treatment Adherence
Временное ограничение: 12 weeks
|
Proportion of participants with good treatment adherence (≥80% of prescribed doses).
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12 weeks
|
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Incidence of Adverse Events
Временное ограничение: 12 weeks
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Frequency and type of treatment-related adverse events during the intervention period.
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12 weeks
|
|
Change in Modified Ferriman-Gallwey Score
Временное ограничение: Baseline and 12 weeks
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Change in Modified Ferriman-Gallwey (mFG) score from baseline to week 12.
The Modified Ferriman-Gallwey scale measures the degree of hirsutism and ranges from 0 to 36, with higher scores indicating greater severity of hirsutism and worse clinical status.
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Baseline and 12 weeks
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Saba Nadeem, FCPS, Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
Публикации и полезные ссылки
Общие 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. doi: 10.1210/clinem/dgad762.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Генитальные заболевания
- Заболевания эндокринной системы
- Новообразования
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Заболевания половых органов, Женский
- Заболевания яичников
- Заболевания придатков
- Заболевания гонад
- Кисты яичников
- Кисты
- Синдром поликистоза яичников
- Бесплодие
- Аминокислоты, пептиды и белки
- Белки
- Органические химические вещества
- Углеводы
- Спирты
- Альбумины
- Сахарные спирты
- Диетические белки
- Молоко белки
- Животные белки, диетические
- Сывороточные белки
- Инозитол
- Лакталбумин
Другие идентификационные номера исследования
- OBG-2025-033-14500
- 509/DME/QAMC Bahawalpur (Другой идентификатор: Quaid-e-Azam Medical College)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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