Clinical trial · Interventional
Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women
NCT07635082CI-TRIAL-00114085completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole 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 |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome (PCOS) Women | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELP (Extended Letrozole Protocol) | Drug | — | UNRESOLVED |
| LIP (Letrozole + Inositol Protocol) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Extended Letrozole Protocol (7 days
- interventionNames
- Drug: ELP (Extended Letrozole Protocol)
- type
- EXPERIMENTAL
- label
- Letrozole + Inositol Protocol
- interventionNames
- Drug: LIP (Letrozole + Inositol Protocol)
Primary outcomes (1)
- measure
- Ovulation Rate
- timeFrame
- At the end of Cycle 1 (each treatment cycle is 28 days).
- description
- The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. * Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles. * Age 18 to 35 years. * Body mass index (BMI) ≤ 30 kg/m². * Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy. * Partner with normal semen analysis. * Willing and able to provide informed consent. Exclusion Criteria: * Thyroid dysfunction. * Hyperprolactinemia. * Diabetes mellitus. * Congenital adrenal hyperplasia. * Adrenal causes of hyperandrogenism. * Use of insulin-sensitizing medications (e.g., metformin) during the study period. * Chronic liver disease. * Chronic kidney disease. * Contraindications to pregnancy. * Contraindications or hypersensitivity to inositol or letrozole.
References
Publications (0)
Data not yet available
No reference posted for this study.