PCOSNCT03667443
Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients
A study testing Myo-inositol + folic a. + α-lactalbumin and Myo-inositol + folic a. in people with PCOS and Myo-inositol-resistance, run by Lo.Li.Pharma s.r.l at 1 site in Bulgaria.
Trial summary
The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- PCOS, Myo-inositol-resistance
- What is being tested?
- Myo-inositol + folic a. + α-lactalbumin and Myo-inositol + folic a.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBulgaria
- Study dates
- 13 Jun 2022to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- POCS women diagnosed using the Rotterdam Criteria
Who cannot join
- Amenorrhea (3 months)
- Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
- Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
- Drastic changes in diet
- Treatment with product containing Myo-inositol in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Myo-inositol Plus Alpha-lactalbumin in Ovulation Induction of PCOS Myo-inositol-resistant Patients
The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients
Read the detailed description
In this study, the investigators expect about 30% of the PCOS patients enrolled to be resistant to Myo-inositol treatment for ovulation induction, probably due to the presence of malabsorption caused by gut dysbiosis. The most recent evidence proposes dysbiosis and related chronic low-grade inflammation as the new DOGMA behind PCOS pathogenesis. In this regard, the recent findings on alpha-lactalbumin reports its effect in improving the absorption of different nutrients including myo-inositol as well as a crucial factor for reducing inflammation. Furthermore, this whey protein is well known for its effect as trophic agent for gastrointestinal flora in infants. For all these reasons, the investigators expect that the treatment with Inofolic HP (Myo-inositol and alpha-lactalbumin) will get an efficacy 20-25% higher than the treatment with inofolic.
- Conditions
- PCOS, Myo-inositol-resistance
- Being tested
- Myo-inositol + folic a. + α-lactalbumin, Myo-inositol + folic a.
- Keywords
- myo-inositol, alpha-lactalbumin, polycystic ovary syndrome, anovulation, infertility
- Medical subject headings
- Polycystic Ovary Syndrome, Anovulation, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol + folic a. + α-lactalbuminDietary supplement
Also called Inofolic HP
3 months of treatment
Myo-inositol + folic a.Dietary supplement
Also called Inofolic
3 months of treatment
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol plus folic | Active comparator | Not described Receives: Dietary Supplement: Myo-inositol + folic a. |
| Myo-inositol + folic a. + α-lactalbumin | Active comparator | Not described Receives: Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovulation induction
Ovulation indaction will by evaluated through ultrasound sonography
Measured: after three months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start13 Jun 2022
- Primary completion26 Oct 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667443
- Sponsor's protocol ID
- MILA
- Status last verified
- Jan 2023
- First submitted
- 1 Aug 2018
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Myo-inositol Plus Alpha-lactalbumin in Ovulation Induction of PCOS Myo-inositol-resistant Patients
- ClinicalTrials.gov ID
- NCT03667443
- Acronym / sponsor ID
- MILA
- Conditions
- PCOS, Myo-inositol-resistance
- Keywords
- myo-inositol, alpha-lactalbumin, polycystic ovary syndrome, anovulation, infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 12 Sep 2018 (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.
The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients
Detailed description
In this study, the investigators expect about 30% of the PCOS patients enrolled to be resistant to Myo-inositol treatment for ovulation induction, probably due to the presence of malabsorption caused by gut dysbiosis. The most recent evidence proposes dysbiosis and related chronic low-grade inflammation as the new DOGMA behind PCOS pathogenesis. In this regard, the recent findings on alpha-lactalbumin reports its effect in improving the absorption of different nutrients including myo-inositol as well as a crucial factor for reducing inflammation. Furthermore, this whey protein is well known for its effect as trophic agent for gastrointestinal flora in infants. For all these reasons, the investigators expect that the treatment with Inofolic HP (Myo-inositol and alpha-lactalbumin) will get an efficacy 20-25% higher than the treatment with inofolic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol plus folic | Active comparator | Dietary Supplement: Myo-inositol + folic a. |
| Myo-inositol + folic a. + α-lactalbumin | Active comparator | Dietary Supplement: Myo-inositol + folic a. + α-lactalbumin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- POCS women diagnosed using the Rotterdam Criteria
Key exclusion criteria (5 listed)
- Amenorrhea (3 months)
- Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
- Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
- Drastic changes in diet
- Treatment with product containing Myo-inositol in the previous 3 months
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-inositol + folic a. + α-lactalbuminAlso: Inofolic HP3 months of treatment | Dietary supplement | Myo-inositol + folic a. + α-lactalbumin |
| Myo-inositol + folic a.Also: Inofolic3 months of treatment | Dietary supplement | Myo-inositol plus folic |
Primary outcome
ovulation induction
Time frame: after three months of treatment
Ovulation indaction will by evaluated through ultrasound sonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 + folic a. + α-lactalbumin and Myo-inositol + folic a. in people with PCOS and Myo-inositol-resistance, run by Lo.Li.Pharma s.r.l at 1 site in Bulgaria.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jul 2025. 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 Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovulation induction (time frame: after three months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.