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The aim of the study is to compare and assess the efficacy of combined letrozole with myoinositol, chromium, or L-arginine in infertile women with PCOS. This study will help in the investigation of alternative therapeutic modalities for fertility improvement in polycystic ovarian syndrome
d prospective Study Trial. We will recruit patients diagnosed with PCOS according to Rotterdam criteria of PCOS and who present to outpatient clinics at Beni-Suef University Hospital. Infertile women will be randomized to receive letrozole (2.5 mg for 5 days from 3rd day of patients' menstrual cycle) combination with myoinositol, chromium or L-arginine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myoinositol | Experimental | patients will be treated for 12 weeks myoinositol (2gm /day) with ovulation induction by letrazole regimen for 3 consecutive cycl |
|
| chromium | Experimental | patients will be treated for 12 weeks chromium ( 281.569 mcg/ day) with ovulation induction by letrazole regimen for 3 consecutive cycles |
|
| L-arginine | Experimental | : patients will be treated for 12 weeks with L-arginine (500 mg once daily in the morning) with ovulation induction by letrazole regimen for 3 consecutive cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoinositol | Drug | Myoinositol decreases insulin resistance and consequently increased intracellular glucose uptake, restore the metabolic profile and induce ovulation in PCOS patients with infertility, in addition to its good safety profile |
| Measure | Description | Time Frame |
|---|---|---|
| ovulation | trans-vaginal ultrasound shows dominant follicle more than 18mm | 3 cycles ( 3 months / one month for each cycle) |
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Inclusion Criteria:
Exclusion Criteria:
3. Use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months.
4. Patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or Cushing syndrome. 5. Presence of hypersensitivity to any of the study medications.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara S Sara Salem | Contact | +201272842226 | sara_abdallah100@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef university Hospital | Banī Suwayf | 62511 | Egypt | |||
| Beni-suef university |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D002857 | Chromium |
| D001120 | Arginine |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| Chromium | Drug | chromium picolinate may potentiates the therapeutic effect of letrozol on pituitary hormones (FSH and LH), improvement of ovulation, normalization of Estrogen level, improvement of endometrial thickness related to ovulation |
|
|
| l-arginine | Drug | new antioxidant that minimizes the inflammatory reaction, the hormonal imbalance, and the metabolic disturbances in PCO |
|
|
| Letrozole 2.5mg | Drug | selective aromatase inhibitor |
|
|
| Banī Suwayf |
| 62511 |
| Egypt |
|
| 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 |
| D019216 |
| Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |