Trial | NCT03674385  Report issue

Title

Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate
Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Jul 19
2018
Primary Completion
Mar 25
2019
Study Completion
Mar 30
2019
Last Update
Jul 10
2020

Dietary Supplement vitamin E

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

  • Other names: toco 1000

Drug Metformin

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)

  • Other names: cidophage

Drug Clomiphene Citrate

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

  • Other names: clomid

vitamin E group Experimental

30 patient

control group Active Comparator

clomiphene

Criteria 

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
No Results Posted