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Completed

NCT Number: NCT03674385

Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Dietary Supplement

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

metformin

Drug

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

Clomiphene Citrate

Drug

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

Other names: clomid

Primary outcomes

  1. ovulation rate

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Misr University for Science and Technology

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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