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Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674385
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Misr University for Science and Technology
Information provided by (Responsible Party):
Ahmed Abbas Morsy Morsy, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Clomiphene Citrate Resistant Polycystic Ovary Syndrome Dietary Supplement: vitamin E Drug: Metformin Drug: Clomiphene Citrate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized controlled open label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Actual Study Start Date : July 19, 2018
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 30, 2019


Arm Intervention/treatment
Experimental: vitamin E group
30 patient
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 Name: 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 Name: cidophage

Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Name: clomid

Active Comparator: control group
clomiphene
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 Name: cidophage

Drug: Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate
Other Name: clomid




Primary Outcome Measures :
  1. ovulation rate [ Time Frame: 3 months ]
    Follicles measure more than 18 mm will be considered mature follicles.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674385


Locations
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Egypt
Medical Center of Infertility
Banī Suwayf, Egypt, 62521
Sponsors and Collaborators
Ain Shams University
Misr University for Science and Technology
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Responsible Party: Ahmed Abbas Morsy Morsy, pharmacist, Ain Shams University
ClinicalTrials.gov Identifier: NCT03674385    
Other Study ID Numbers: PHCL 191
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Abbas Morsy Morsy, Ain Shams University:
Vitamin E
Polycystic ovary
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamin E
Metformin
Clomiphene
Enclomiphene
Zuclomiphene
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female