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

5. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

82

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Legemiddel: 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.
Eksperimentell: 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.
Legemiddel: 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.
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Spontaneous Conception Rate
Tidsramme: 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
Tidsramme: 12 weeks
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
12 weeks

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Quaid-e-Azam Medical College

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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