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

June 1, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous Conception Rate
Time Frame: 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
Time Frame: 12 weeks
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Ferriman-Gallwey Score
Time Frame: Baseline and 12 weeks
Change in modified Ferriman-Gallwey (mFG) score from baseline to week 12.
Baseline and 12 weeks
Change in Body Mass Index
Time Frame: 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
Time Frame: Baseline and 12 weeks
Change in serum luteinizing hormone concentration from baseline to week 12.
Baseline and 12 weeks
Change in LH/FSH Ratio
Time Frame: 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
Time Frame: Baseline and 12 weeks
Change in fasting glucose level from baseline to week 12.
Baseline and 12 weeks
Change in Fasting Insulin
Time Frame: Baseline and 12 weeks
Change in fasting insulin level from baseline to week 12.
Baseline and 12 weeks
Change in HOMA-IR
Time Frame: 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
Time Frame: 12 weeks
Proportion of participants with good treatment adherence (≥80% of prescribed doses).
12 weeks
Incidence of Adverse Events
Time Frame: 12 weeks
Frequency and type of treatment-related adverse events during the intervention period.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quaid-e-Azam Medical College

Investigators

  • Study Chair: Saba Nadeem, FCPS, Sadiq Abbasi Hospital/Quaid-e-Azam Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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