NCT07629895Not yet recruiting
Myo-Inositol Alone Versus Myo-Inositol Plus Alpha-Lactalbumin in Women With Polycystic Ovary Syndrome
Comparison of Efficacy of Myo-Inositol Alone With Myo-Inositol Plus Alpha-Lactalbumin on Reproductive and Metabolic Parameters in Polycystic Ovarian Syndrome
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Quaid-e-Azam Medical College
- NCT number
- NCT07629895
What you commit to
- Study type: Interventional
- Planned participants: 82
- From Sept 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of ovulation-induction agents, hormonal therapy, insulin sensitizers, or anti-androgens within the previous 12 weeks.
Other illness
- Pre-existing diabetes mellitus.
- Cushing syndrome.
- Conditions causing ovulatory dysfunction and/or hyperandrogenism other than PCOS.
- Known cow milk protein allergy, hypersensitivity to study medications, or severe gastrointestinal malabsorption.
- Hepatic, renal, or cardiovascular impairment.
Other
- Thyroid dysfunction.
- Hyperprolactinemia.
- Congenital adrenal hyperplasia.
- Androgen-secreting adrenal or ovarian tumors.
- Morbid obesity (BMI ≥40 kg/m²).
- Tubal factor infertility.
- Endometriosis.
- Structural uterine abnormality.
- Male factor infertility.
Who the study is looking for
- 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.
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sadiq Abbasi Hospital/ Quaid-e-Azam Medical College Coordinator of this site? Confirm its status | Chak Eighty-seven -Twelve Left | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.