Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

Ain Shams University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Interventions

vitamin EDIETARY_SUPPLEMENT

Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect

MetforminDRUG

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)

Clomiphene CitrateDRUG

is a medication used to treat infertility in women who do not ovulate

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS 2. Age between 18 and 39 years. 3. Period of infertility \>1 years. 4. No treatment taken during the last 2 months. 5. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance Exclusion Criteria: 1. History of pelvic surgery or infertility factor other than anovulation 2. Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations. 3. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency. 4. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date. 5. Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%). 6. Elevated serum prolactin, T.S.H and F.S.H. 7. Patients diagnosed with diabetes mellitus

Locations (1)

Medical Center of Infertility

Banī Suwayf, Egypt

Outcomes

Primary Outcomes

ovulation rate

Follicles measure more than 18 mm will be considered mature follicles.

Time frame: 3 months

Data from ClinicalTrials.gov

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