PCOS (Polycystic Ovary Syndrome)Phase 3NCT07323589
Impact of Myo-Inositol Alone vs Myo-Inositol Plus Metformin on Conception, Adherence, and Tolerability in PCOS
A Phase 3 study testing Myoinositol and Metformin 1500 mg daily in people with PCOS (Polycystic Ovary Syndrome), run by PAEC general hospital at 1 site in Pakistan.
Trial summary
The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Myoinositol and Metformin 1500 mg daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 25 Oct 2025
- Phase
- Phase 3
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20 to 35 years
- BMI ≥25 kg/m²
- Fulfilled at least two of the three Rotterdam criteria for PCOS
- Attempting to conceive naturally
- No use of hormonal drugs or insulin-sensitizers in the past three months
Who cannot join
- Endocrine disorders (e.g., diabetes, thyroid dysfunction)
- Hepatic impairment
- Kidney disease
- Gastrointestinal or malabsorption issues (IBS, IBD, celiac disease)
- Known allergies to metformin or inositol
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Myo-Inositol vs Combined Myo-Inositol and Metformin Therapy on Conception Rates, Treatment Adherence, and Tolerability in Overweight Women Diagnosed With PCOS: A Randomized Controlled Study
The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS).
The main questions it aims to answer are:
Read more
- Does myo-inositol alone achieve conception rates comparable to the combination of myo-inositol and metformin?
- Does the combination therapy result in more side effects and lower compliance compared to myo-inositol alone? If there is a comparison group: Researchers will compare Group A (myo-inositol 4 g/day) with Group B (myo-inositol 4 g/day + metformin 1500 mg/day) to see if the addition of metformin improves conception outcomes but at the cost of tolerability.
Participants will:
- Be randomly assigned to receive either myo-inositol alone or myo-inositol plus metformin for six months.
- Attend follow-up visits for monitoring of pregnancy outcomes confirmed by ultrasound.
- Report any side effects experienced during treatment.
- Provide information on treatment adherence and dropout rates.
- Be assessed for menstrual regularity and ovulation rates.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Myoinositol, Metformin 1500 mg daily
- Keywords
- Myo-inositol, Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoinositolDrug
myo-inositol (4 g/day)
Metformin 1500 mg dailyDrug
metfromin plus myoinositol 1500mg and 4gram per day respectively
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day) Receives: Drug: Myoinositol |
| arm 2 | Experimental | group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day) Receives: Drug: Myoinositol; Drug: Metformin 1500 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Confirmed Clinical Pregnancy by Ultrasound
Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.
Measured: Up to 6 months or until pregnancy is confirmed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2025
- Primary completion30 Jul 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCOS (Polycystic Ovary Syndrome)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- PAEC general hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Amin, PAEC general hospital
- Investigators
- Maria Amin, Principal investigator, PAEC general hospital, H-11/4, islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323589
- Sponsor's protocol ID
- PGHI-IRB(DME)-RCD-06-097
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agrawal A, Mahey R, Kachhawa G, Khadgawat R, Vanamail P, Kriplani A. Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial. Gynecol Endocrinol. 2019 Jun;35(6):511-514. doi: 10.1080/09513590.2018.1549656. Epub 2019 Jan 7.
PubMed 30614289Thakur SS, Anjum S, Siddiqui SS. Randomised controlled trial: comparing effects of metformin versus myoinositol versus metformin and myoinositol on ovarian functions and metabolic factors in polycystic ovarian syndrome. Int J Reprod Contracept Obstet Gynecol. 2020;9(6):2542 50. doi:10.18203/2320-1770.ijrcog20202030
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Myo-Inositol vs Combined Myo-Inositol and Metformin Therapy on Conception Rates, Treatment Adherence, and Tolerability in Overweight Women Diagnosed With PCOS: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07323589
- Acronym / sponsor ID
- PGHI-IRB(DME)-RCD-06-097
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- Myo-inositol, Polycystic Ovary Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- PAEC general hospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 7 Jan 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.
The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS).
The main questions it aims to answer are:
- Does myo-inositol alone achieve conception rates comparable to the combination of myo-inositol and metformin?
- Does the combination therapy result in more side effects and lower compliance compared to myo-inositol alone? If there is a comparison group: Researchers will compare Group A (myo-inositol 4 g/day) with Group B (myo-inositol 4 g/day + metformin 1500 mg/day) to see if the addition of metformin improves conception outcomes but at the cost of tolerability.
Participants will:
- Be randomly assigned to receive either myo-inositol alone or myo-inositol plus metformin for six months.
- Attend follow-up visits for monitoring of pregnancy outcomes confirmed by ultrasound.
- Report any side effects experienced during treatment.
- Provide information on treatment adherence and dropout rates.
- Be assessed for menstrual regularity and ovulation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: Myoinositolin the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day) |
| arm 2 | Experimental | Drug: Myoinositol, Drug: Metformin 1500 mg dailygroup B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 20 to 35 years
- BMI ≥25 kg/m²
- Fulfilled at least two of the three Rotterdam criteria for PCOS
- Attempting to conceive naturally
- No use of hormonal drugs or insulin-sensitizers in the past three months
Key exclusion criteria (6 listed)
- Endocrine disorders (e.g., diabetes, thyroid dysfunction)
- Hepatic impairment
- Kidney disease
- Gastrointestinal or malabsorption issues (IBS, IBD, celiac disease)
- Known allergies to metformin or inositol
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 |
|---|---|---|
| Myoinositolmyo-inositol (4 g/day) | Drug | arm 1, arm 2 |
| Metformin 1500 mg dailymetfromin plus myoinositol 1500mg and 4gram per day respectively | Drug | arm 2 |
Primary outcome
Number of Participants with Confirmed Clinical Pregnancy by Ultrasound
Time frame: Up to 6 months or until pregnancy is confirmed
Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.
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 7 Jan 2026.
- Results publication: PubMed 30614289Agrawal A, Mahey R, Kachhawa G, Khadgawat R, Vanamail P, Kriplani A. Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial. Gynecol Endocrinol. 2019 Jun;35(6):511-514. doi: 10.1080/09513590.2018.1549656. Epub 2019 Jan 7.
- Results publicationThakur SS, Anjum S, Siddiqui SS. Randomised controlled trial: comparing effects of metformin versus myoinositol versus metformin and myoinositol on ovarian functions and metabolic factors in polycystic ovarian syndrome. Int J Reprod Contracept Obstet Gynecol. 2020;9(6):2542 50. doi:10.18203/2320-1770.ijrcog20202030
- Individual participant dataSharing planned: No
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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.
Maria Amin principal investigator
PAEC general hospital, H-11/4, islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myoinositol and Metformin 1500 mg daily in people with PCOS (Polycystic Ovary Syndrome), run by PAEC general hospital 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 6 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 7 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of Participants with Confirmed Clinical Pregnancy by Ultrasound (time frame: Up to 6 months or until pregnancy is confirmed). 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 NCT07323589, which also lists 2 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 7 Jan 2026.