Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Conditions
Keywords
Vitamin E, Polycystic ovary
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTvitamin E
Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect
DRUGMetformin
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)
DRUGClomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Sponsors
Misr University for Science and Technology
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective randomized controlled open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovulation rate | 3 months | Follicles measure more than 18 mm will be considered mature follicles. |
Countries
Egypt
Outcome results
None listed