Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

Study Overview
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Brief Summary
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This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only.

Detailed Description
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Clomiphene and vit E each used in treatment of pco but they do so by different mechanisms. Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary. Vit E is used in treatment of pco due its anti-oxidant effect.

Official Title
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Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Conditions
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Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: vitamin E
* Drug: Metformin
* Drug: Clomiphene Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS Age between 18 and 39 years. Period of infertility >1 years. No treatment taken during the last 2 months. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance Exclusion Criteria: History of pelvic surgery or infertility factor other than anovulation Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date. Male factor infertility (sperm count < 5 million per milliliter, normal morphology <4%). Elevated serum prolactin, T.S.H and F.S.H. Patients diagnosed with diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin E group<br>30 patient | Dietary Supplement: vitamin E<br>* Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect<br>* Other names: toco 1000;Drug: Metformin<br>* Metformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS)<br>* Other names: cidophage;Drug: Clomiphene Citrate<br>* is a medication used to treat infertility in women who do not ovulate<br>* Other names: clomid;|
| Active Comparator: control group<br>clomiphene | Drug: Metformin<br>* Metformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS)<br>* Other names: cidophage;Drug: Clomiphene Citrate<br>* is a medication used to treat infertility in women who do not ovulate<br>* Other names: clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation rate | Follicles measure more than 18 mm will be considered mature follicles. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin E, Polycystic ovary