Clinical trial · Interventional
Inositol in Letrozol Resistant PCOS Women
Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women
NCT07585396CI-TRIAL-00119669completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Myoinositol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Myoinositol group
- description
- 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.
- interventionNames
- Drug: Myoinositol
- type
- ACTIVE_COMPARATOR
- label
- Metformin group
- description
- 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.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 38 Years
Show eligibility criteria text
Inclusion Criteria: * • Age between 20- 38 years old. * Diagnosis of PCOS according to Rotterdam criteria * Letrozole resistant cases. * Normal thyroid hormone level. * Normal prolactin hormone level. Exclusion Criteria: * • History of ovarian surgery. * cases associated with endometriosis. * History of diabetes mellitus. * Allergy to myo-Inositol .
References
Publications (0)
Data not yet available
No reference posted for this study.