Polycystic Ovary SyndromePhase 2/3NCT07585396
Inositol in Letrozol Resistant PCOS Women
A Phase 2/3 study testing Myoinositol and Metformin in people with Polycystic Ovary Syndrome and Infertility, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility
- What is being tested?
- Myoinositol and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2024to 11 Jul 2026
- Phase
- Phase 2/3
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Age between 20- 38 years old.
- Diagnosis of PCOS according to Rotterdam criteria
- Letrozole resistant cases.
- Normal thyroid hormone level.
- Normal prolactin hormone level.
Who cannot join
- • History of ovarian surgery.
- cases associated with endometriosis.
- History of diabetes mellitus.
- Allergy to myo-Inositol .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.
Read the detailed description
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age .Furthermore, impaired glucose tolerance affects 30 - 40 % of women with PCOS and the pathophysiology of insulin resistance appears to be linked to a malfunction in the insulin signalling system. Insulin-sensitizing substances, including the B-complex vitamin inositol and its stereoisomers (myo-inositol and D-chiro-inositol )have therefore been investigated as a potential treatment for PCOS.
Letrozole is the recommended medication for ovulation induction in PCOS-related infertility since it produces higher pregnancy and live birth rates than Clomphine Citrate. Alternative regimens, such as two-step, higher, and prolonged doses, may be necessary for women who are not responding to the standard letrozole dosage. However, some women might not respond to letrozole even at the highest dosage.
Inositols are produced by the human body and are a member of the vitamin B complex group.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways. They positively influence menstrual cycle regularity, carbohydrate metabolism, and the clinical and laboratory symptoms of hyperandrogenism (e.g., free testosterone, total testosterone, SHBG).
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Being tested
- Myoinositol, Metformin
- Keywords
- Inositol, Letrozol, PCOS
- 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.
MyoinositolDrug
Myo-inositol 2 g orally twice daily (4 g/day) for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study.
MetforminDrug
Metformin initiated at 500 mg orally once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day, administered for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Myoinositol group | Active comparator | Phase A (Priming phase) : myo-inositol 2 g twice daily for 8 weeks Phase B ( ovulation induction ): letrozole 7.5 mg/day on cycle days 3-7 for up to three cycles or until clinical pregnancy. Folic acid 400 µg/day is administered throughout the study. Receives: Drug: Myoinositol |
| Metformin group | Active comparator | PhaseA( priming phase) : Metformin initiated at 500mg oral once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day Phase B(induction ) : letrozole 7.5 mg/day on cycle days 3-7 for three consecutive cycles or until clinical pregnancy Folic acid 400 µg/day is administered throughout the study. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound
Measured: 5 months (8 weeks priming phase + 3 consecutive cycles of letrozole )
Secondary outcomes (1)
* clinical pregnancy
Percentage of participants who achieve a clinical pregnancy, defined as visualization of an intrauterine gestational sac with fetal cardiac activity by transvaginal ultrasound.
Measured: 5 months ( 8weeks of priming phase + 3 consecutive cycles of letrozole )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start10 Apr 2024
- Primary completion10 Jun 2026
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohsen Mahnoud Aboelkhier, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585396
- Sponsor's protocol ID
- KFSIRB200-600
- Status last verified
- Sep 2026
- First submitted
- 7 May 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women
- ClinicalTrials.gov ID
- NCT07585396
- Acronym / sponsor ID
- KFSIRB200-600
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Keywords
- Inositol, Letrozol, PCOS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 11 Jul 2026 (actual)
- First posted
- 13 May 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 complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.
Detailed description
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age .Furthermore, impaired glucose tolerance affects 30 - 40 % of women with PCOS and the pathophysiology of insulin resistance appears to be linked to a malfunction in the insulin signalling system. Insulin-sensitizing substances, including the B-complex vitamin inositol and its stereoisomers (myo-inositol and D-chiro-inositol )have therefore been investigated as a potential treatment for PCOS.
Letrozole is the recommended medication for ovulation induction in PCOS-related infertility since it produces higher pregnancy and live birth rates than Clomphine Citrate. Alternative regimens, such as two-step, higher, and prolonged doses, may be necessary for women who are not responding to the standard letrozole dosage. However, some women might not respond to letrozole even at the highest dosage.
Inositols are produced by the human body and are a member of the vitamin B complex group.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways. They positively influence menstrual cycle regularity, carbohydrate metabolism, and the clinical and laboratory symptoms of hyperandrogenism (e.g., free testosterone, total testosterone, SHBG).
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: MyoinositolPhase A (Priming phase) : myo-inositol 2 g twice daily for 8 weeks Phase B ( ovulation induction ): letrozole 7.5 mg/day on cycle days 3-7 for up to three cycles or until clinical pregnancy. Folic acid 400 µg/day is administered throughout the study. |
| Metformin group | Active comparator | Drug: MetforminPhaseA( priming phase) : Metformin initiated at 500mg oral once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day Phase B(induction ) : letrozole 7.5 mg/day on cycle days 3-7 for three consecutive cycles or until clinical pregnancy Folic acid 400 µg/day is administered throughout the study. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Age between 20- 38 years old.
Key exclusion criteria (4 listed)
- • History of ovarian surgery.
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 2 g orally twice daily (4 g/day) for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study. | Drug | Myoinositol group |
| MetforminMetformin initiated at 500 mg orally once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day, administered for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study. | Drug | Metformin group |
Primary outcome
Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound
Time frame: 5 months (8 weeks priming phase + 3 consecutive cycles of letrozole )
1 secondary outcome
* clinical pregnancy
Time frame: 5 months ( 8weeks of priming phase + 3 consecutive cycles of letrozole )
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 29 Sep 2026.
- 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.
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 Phase 2/3 study testing Myoinositol and Metformin in people with Polycystic Ovary Syndrome and Infertility, run by Kafrelsheikh 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 5 inclusion and 4 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 29 Sep 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound (time frame: 5 months (8 weeks priming phase + 3 consecutive cycles of letrozole )). 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 29 Sep 2026.