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Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Letrozole Protocol (7 days | Placebo Comparator |
| |
| Letrozole + Inositol Protocol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELP (Extended Letrozole Protocol) | Drug | ? ELP (Extended Letrozole Protocol) Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days. Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation. When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly. Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation Rate | 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. | At the end of Cycle 1 (each treatment cycle is 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Ovulation Rate | The proportion of participants who achieve spontaneous ovulation during the study period. | Up to 3 months after treatment initiation. |
| Clinical Pregnancy Rate | The proportion of participants with clinical pregnancy confirmed by transvaginal ultrasonographic visualization of a gestational sac. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University Hospital | Kafr ash Shaykh | Kafr el-Sheikh Governorate | 33511 | Egypt |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2025 |
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| LIP (Letrozole + Inositol Protocol) | Drug | ? LIP (Letrozole + Inositol Protocol) Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction. In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days. Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed. Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse. Compliance with inositol intake and any adverse effects will be documented throughout the study period. |
|
| Up to 12 weeks after treatment initiation. |
| Jun 4, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C514704 | SMG1 protein, human |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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