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

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.

Study Overview

• Status: Completed
• Conditions: Clomiphene Citrate Resistant Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Clomiphene Citrate; Dietary supplement: vitamin E; Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62521
    • Medical Center of Infertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; clomiphene	Drug: Clomiphene Citrate; is a medication used to treat infertility in women who do not ovulate; Other Names: clomid; 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
Experimental: vitamin E group; 30 patient	Drug: Clomiphene Citrate; is a medication used to treat infertility in women who do not ovulate; Other Names: clomid; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovulation rate	Follicles measure more than 18 mm will be considered mature follicles.	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Misr University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): March 25, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Vitamin E; Polycystic ovary
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Micronutrients; Hormone Antagonists; Vitamins; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Antioxidants; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Metformin; Vitamin E; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: PHCL 191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No