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The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.
simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation & decreasing steroidogenesis (production of progesterone & testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia& hyperandrogenism .This study will test the hypothesis that simvastatin improves biochemical parameters& IVF-ICSI outcome in Pcos patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIMVASTATIN | Drug | 20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| ivf-et outcomes | 14-20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical parameters baseline and 8weeks Biochemical parameters | baseline and 8weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| batool hossein rashidi, MD | Tehran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam Khomeiny Hospital | Tehran | 1419733141 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37462232 | Derived | Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3. | |
| 21527854 | Derived | Rashidi B, Abediasl J, Tehraninejad E, Rahmanpour H, Sills ES. Simvastatin effects on androgens, inflammatory mediators, and endogenous pituitary gonadotropins among patients with PCOS undergoing IVF: results from a prospective, randomized, placebo-controlled clinical trial. J Investig Med. 2011 Aug;59(6):912-6. doi: 10.2310/JIM.0b013e31821bfd9c. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| C565840 | Long Qt Syndrome 3 |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |