Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

• ClinicalTrials.gov Identifier: NCT03674385
• Recruitment Status: Completed
• First Posted: September 17, 2018
• Last Update Posted: July 10, 2020
• Sponsor: Ain Shams University
• Collaborator: Misr University for Science and Technology
• Information provided by (Responsible Party): Ahmed Abbas Morsy Morsy, Ain Shams University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Medical Center of Infertility

Banī Suwayf, Egypt, 62521

Sponsors and Collaborators

Ain Shams University

Misr University for Science and Technology

More Information

• 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
• Last Update Posted: July 10, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Polycystic Ovary Syndrome; Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Vitamin E; Metformin; Clomiphene; Enclomiphene; Zuclomiphene; Vitamins; Micronutrients; 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; Fertility Agents; Reproductive Control Agents; Selective Estrogen Receptor Modulators