PCOSNCT07058675
Myoinositol vs. Metformin for Polycystic Ovarian Syndrome (PCOS): Impact on Metabolic Health and Fertility
A study testing Metformin Hydrochloride 500 MG and Myoinositol in people with PCOS, run by Benha University at 1 site in Egypt.
Trial summary
The study aimed to assess how a 6-month insulin sensitizer therapy impacts insulin resistance, glucose tolerance, and hormonal levels in women with PCOS. Researchers evaluated 156 PCOS patients, measuring their BMI, HOMA-IR (for insulin resistance), TyG index, TyG index-BMI, and total testosterone. Read more about this study
- Who is it for?
- Ages 23 to 47 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Metformin Hydrochloride 500 MG and Myoinositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2024to 18 Jun 2025
- 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 23 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting manifestations suggestive of having PCOS;
- Patients were free of exclusion criteria.
Who cannot join
- Patients who were maintained on a diet regimen, or/and regular exercise;
- Patients who were on medical therapy of PCOS, antidiabetic or/and antihypertensive therapy;
- Patients who underwent laparoscopic drilling;
- Patients with dyslipidemia, hereditary lipoprotein disorders:
- Patients with chronic liver or kidney diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myoinositol Therapy May Adjust The Metabolic Deregulation in Infertile Polycystic Ovarian Syndrome (PCOS) Women Through Modulation of The TyG Index-BMI: A Comparative Study Versus Metformin
The study aimed to assess how a 6-month insulin sensitizer therapy impacts insulin resistance, glucose tolerance, and hormonal levels in women with PCOS. Researchers evaluated 156 PCOS patients, measuring their BMI, HOMA-IR (for insulin resistance), TyG index, TyG index-BMI, and total testosterone. Participants were divided into two groups, receiving either metformin or a myoinositol/d-chiro-inositol combination for six months, after which all parameters were re-evaluated to determine the percentage of change.
- Conditions
- PCOS
- Being tested
- Metformin Hydrochloride 500 MG, Myoinositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 500 MGDrug
metformin (MET) hydrochloride 500 mg three times daily as the standard insulin sensitizer.
MyoinositolDrug
Also called myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio
myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratiotwice daily
| Study group | Role | What they receive |
|---|---|---|
| Myoinositol Group | Active comparator | Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took the tablets containing myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio Receives: Drug: Myoinositol |
| Metformin Group | Active comparator | Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg Receives: Drug: Metformin Hydrochloride 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy
The proportion of patients who regained a regular menstrual pattern and/or achieved pregnancy during the study, reflecting the effectiveness of the administered treatment regimens.
Measured: 6~7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start25 Nov 2024
- Primary completion30 May 2025
- Study completion18 Jun 2025
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.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058675
- Sponsor's protocol ID
- RC 1-11-2024
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myoinositol Therapy May Adjust The Metabolic Deregulation in Infertile Polycystic Ovarian Syndrome (PCOS) Women Through Modulation of The TyG Index-BMI: A Comparative Study Versus Metformin
- ClinicalTrials.gov ID
- NCT07058675
- Acronym / sponsor ID
- RC 1-11-2024
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 10 Jul 2025 (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 study aimed to assess how a 6-month insulin sensitizer therapy impacts insulin resistance, glucose tolerance, and hormonal levels in women with PCOS. Researchers evaluated 156 PCOS patients, measuring their BMI, HOMA-IR (for insulin resistance), TyG index, TyG index-BMI, and total testosterone. Participants were divided into two groups, receiving either metformin or a myoinositol/d-chiro-inositol combination for six months, after which all parameters were re-evaluated to determine the percentage of change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myoinositol Group | Active comparator | Drug: MyoinositolPatients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took the tablets containing myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio |
| Metformin Group | Active comparator | Drug: Metformin Hydrochloride 500 MGPatients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg |
Who may qualify
- Ages
- 23 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients presenting manifestations suggestive of having PCOS;
- Patients were free of exclusion criteria.
Key exclusion criteria (5 listed)
- Patients who were maintained on a diet regimen, or/and regular exercise;
- Patients who were on medical therapy of PCOS, antidiabetic or/and antihypertensive therapy;
- Patients who underwent laparoscopic drilling;
- Patients with dyslipidemia, hereditary lipoprotein disorders:
- Patients with chronic liver or kidney diseases.
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 |
|---|---|---|
| Metformin Hydrochloride 500 MGmetformin (MET) hydrochloride 500 mg three times daily as the standard insulin sensitizer. | Drug | Metformin Group |
| MyoinositolAlso: myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratiomyoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratiotwice daily | Drug | Myoinositol Group |
Primary outcome
Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy
Time frame: 6~7 Months
The proportion of patients who regained a regular menstrual pattern and/or achieved pregnancy during the study, reflecting the effectiveness of the administered treatment regimens.
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 10 Jul 2025.
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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 Metformin Hydrochloride 500 MG and Myoinositol in people with PCOS, run by Benha University at 1 site in Egypt.
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 2 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 10 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 Egypt. 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?
Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy (time frame: 6~7 Months). 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 10 Jul 2025.