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Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome (MIALA-PCOS)

5 juin 2026 mis à jour par: Sara Reza, Quaid-e-Azam Medical College

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

82

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Chak Four Hundred Fifty-four, Punjab Province, Pakistan, 63100
        • Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Médicament: 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.
Expérimental: 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.
Médicament: 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.
Complément alimentaire: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Spontaneous Conception Rate
Délai: 12 weeks
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
Délai: 12 weeks
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Body Mass Index
Délai: 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
Délai: Baseline and 12 weeks
Change in serum luteinizing hormone concentration from baseline to week 12.
Baseline and 12 weeks
Change in LH/FSH Ratio
Délai: Baseline and 12 weeks
Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12.
Baseline and 12 weeks
Change in Fasting Glucose
Délai: Baseline and 12 weeks
Change in fasting glucose level from baseline to week 12.
Baseline and 12 weeks
Change in Fasting Insulin
Délai: Baseline and 12 weeks
Change in fasting insulin level from baseline to week 12.
Baseline and 12 weeks
Change in HOMA-IR
Délai: Baseline and 12 weeks
Change in insulin resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
Baseline and 12 weeks
Treatment Adherence
Délai: 12 weeks
Proportion of participants with good treatment adherence (≥80% of prescribed doses).
12 weeks
Incidence of Adverse Events
Délai: 12 weeks
Frequency and type of treatment-related adverse events during the intervention period.
12 weeks
Change in Modified Ferriman-Gallwey Score
Délai: Baseline and 12 weeks
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.
Baseline and 12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Quaid-e-Azam Medical College

Les enquêteurs

  • Chaise d'étude: Saba Nadeem, FCPS, Sadiq Abbasi Hospital/Quaid-e-Azam Medical College

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OBG-2025-033-14500
  • 509/DME/QAMC Bahawalpur (Autre identifiant: Quaid-e-Azam Medical College)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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