Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03674385

Collaborator

Misr University for Science and Technology (Other)

Enrollment

Location

Arms

8.3

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective randomized controlled open label studyprospective 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 :

Jul 19, 2018

Actual Primary Completion Date :

Mar 25, 2019

Actual Study Completion Date :

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

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 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

Drug: Clomiphene Citrate

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

Other Names:

clomid

Active Comparator: control group

clomiphene

Drug: Metformin

Other Names:

cidophage

Drug: Clomiphene Citrate

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

Other Names:

clomid

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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