Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

Clomiphene Citrate Resistant Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674385
• Other study ID #: PHCL 191
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Clomiphene Citrate Resistant Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

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)
• Clomiphene Citrate
is a medication used to treat infertility in women who do not ovulate

Locations

Country	Name	City	State
Egypt	Medical Center of Infertility	Bani Suwayf

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation rate	Follicles measure more than 18 mm will be considered mature follicles.	3 months