Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
PCOS, Myo-Inositol, Alpha-Lactalbumin, Infertility, HOMA-IR, Reproductive Outcomes, Metabolic Parameters
Brief summary
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
DRUGMyo-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_SUPPLEMENTAlpha-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.
Sponsors
Quaid-e-Azam Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either myo-inositol alone or myo-inositol plus alpha-lactalbumin for 12 weeks. Outcomes will be compared between the two parallel treatment groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Conception Rate | 12 weeks | Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test. |
| Achievement of Menstrual Regularity | 12 weeks | Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Ferriman-Gallwey Score | 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. |
| Change in Body Mass Index | Baseline and 12 weeks | Change in body mass index (kg/m²) from baseline to week 12. |
| Change in Serum Luteinizing Hormone Level | Baseline and 12 weeks | Change in serum luteinizing hormone concentration from baseline to week 12. |
| Change in LH/FSH Ratio | Baseline and 12 weeks | Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12. |
| Change in Fasting Glucose | Baseline and 12 weeks | Change in fasting glucose level from baseline to week 12. |
| Change in Fasting Insulin | Baseline and 12 weeks | Change in fasting insulin level from baseline to week 12. |
| Change in HOMA-IR | Baseline and 12 weeks | Change in insulin resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12. |
| Treatment Adherence | 12 weeks | Proportion of participants with good treatment adherence (≥80% of prescribed doses). |
| Incidence of Adverse Events | 12 weeks | Frequency and type of treatment-related adverse events during the intervention period. |
Countries
Pakistan
Contacts
CONTACTKaleem A Dr, FCPS
STUDY_CHAIRSaba Nadeem, FCPS
Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
Outcome results
None listed