Polycystic Ovary Syndrome (PCOS)MIALA-PCOSNCT07629895
Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome
A study testing Myo-inositol and Alpha-Lactalbumin in people with Polycystic Ovary Syndrome (PCOS), run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Myo-inositol and Alpha-Lactalbumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pre-existing diabetes mellitus.
- Thyroid dysfunction.
- Hyperprolactinemia.
- Cushing syndrome.
- Congenital adrenal hyperplasia.
- Androgen-secreting adrenal or ovarian tumors.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Myo-inositol, Alpha-Lactalbumin
- Keywords
- PCOS, Myo-Inositol, Alpha-Lactalbumin, Infertility, HOMA-IR, Reproductive Outcomes, Metabolic Parameters
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositolDrug
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-LactalbuminDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Myo-Inositol Alone | Active comparator | 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. Receives: Drug: Myo-inositol |
| Myo-Inositol Plus Alpha-Lactalbumin | Experimental | 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. Receives: Drug: Myo-inositol; Dietary Supplement: Alpha-Lactalbumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Conception Rate
Proportion of participants achieving spontaneous conception without ovulation induction or assisted reproductive technologies, confirmed by a positive urinary pregnancy test.
Measured: 12 weeks
Achievement of Menstrual Regularity
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
Measured: 12 weeks
Secondary outcomes (9)
Change in Modified Ferriman-Gallwey Score
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.
Measured: Baseline and 12 weeks
Change in Body Mass Index
Change in body mass index (kg/m²) from baseline to week 12.
Measured: Baseline and 12 weeks
Change in Serum Luteinizing Hormone Level
Change in serum luteinizing hormone concentration from baseline to week 12.
Measured: Baseline and 12 weeks
Change in LH/FSH Ratio
Change in luteinizing hormone to follicle-stimulating hormone ratio from baseline to week 12.
Measured: Baseline and 12 weeks
Change in Fasting Glucose
Change in fasting glucose level from baseline to week 12.
Measured: Baseline and 12 weeks
Change in Fasting Insulin
Change in fasting insulin level from baseline to week 12.
Measured: Baseline and 12 weeks
Change in HOMA-IR
Change in insulin resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 12.
Measured: Baseline and 12 weeks
Treatment Adherence
Proportion of participants with good treatment adherence (≥80% of prescribed doses).
Measured: 12 weeks
Incidence of Adverse Events
Frequency and type of treatment-related adverse events during the intervention period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Reza, Quaid-e-Azam Medical College
- Investigators
- Saba Nadeem, FCPS, Study chair, Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629895
- Sponsor's protocol ID
- OBG-2025-033-14500
- Other IDs
- 509/DME/QAMC Bahawalpur
- Acronym
- MIALA-PCOS
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38163998Teede 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.
PubMed 37580314Kamenov 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.
PubMed 37367875
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07629895
- Acronym / sponsor ID
- MIALA-PCOS / OBG-2025-033-14500
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- PCOS, Myo-Inositol, Alpha-Lactalbumin, Infertility, HOMA-IR, Reproductive Outcomes, Metabolic Parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Myo-Inositol Alone | Active comparator | Drug: Myo-inositolParticipants 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. |
| Myo-Inositol Plus Alpha-Lactalbumin | Experimental | Drug: Myo-inositol, Dietary Supplement: Alpha-LactalbuminParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- Pre-existing diabetes mellitus.
- Thyroid dysfunction.
- Hyperprolactinemia.
- Cushing syndrome.
- Congenital adrenal hyperplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myo-inositolMyo-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. | Drug | Myo-Inositol Alone, Myo-Inositol Plus Alpha-Lactalbumin |
| Alpha-LactalbuminAlpha-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. | Dietary supplement | Myo-Inositol Plus Alpha-Lactalbumin |
Primary outcome
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.
Achievement of Menstrual Regularity
Time frame: 12 weeks
Proportion of participants achieving regular menstrual cycles of 21 to 35 days during the treatment period.
9 secondary outcomes
Change in Modified Ferriman-Gallwey Score
Time frame: Baseline and 12 weeks
Change in Body Mass Index
Time frame: Baseline and 12 weeks
Change in Serum Luteinizing Hormone Level
Time frame: Baseline and 12 weeks
Change in LH/FSH Ratio
Time frame: Baseline and 12 weeks
Change in Fasting Glucose
Time frame: Baseline and 12 weeks
Change in Fasting Insulin
Time frame: Baseline and 12 weeks
Change in HOMA-IR
Time frame: Baseline and 12 weeks
Treatment Adherence
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 38163998Fitz 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.
- Results publication: PubMed 37580314Teede 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.
- Results publication: PubMed 37367875Kamenov 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saba Nadeem, FCPS study chair
Sadiq Abbasi Hospital/Quaid-e-Azam Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-inositol and Alpha-Lactalbumin in people with Polycystic Ovary Syndrome (PCOS), run by Quaid-e-Azam Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaleem A Dr, FCPS (+92-302-4750515, sara.qmc@qamc.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Conception Rate (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07629895, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.