Overview

Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

Status:
Completed
Trial end date:
2019-03-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ain Shams University
Collaborator:
Misr University for Science and Technology
Treatments:
alpha-Tocopherol
Citric Acid
Clomiphene
Enclomiphene
Metformin
Sodium Citrate
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Zuclomiphene
Criteria
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