Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

NCT ID: NCT03674385

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2019-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled open label study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vitamin E group

30 patient

Group Type EXPERIMENTAL

vitamin E

Intervention Type DIETARY_SUPPLEMENT

Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect

Metformin

Intervention Type DRUG

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

Intervention Type DRUG

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

control group

clomiphene

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DRUG

Clomiphene Citrate

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

Intervention Type DRUG

Other Intervention Names

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toco 1000 cidophage clomid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Misr University for Science and Technology

OTHER

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abbas Morsy Morsy

pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical Center of Infertility

Banī Suwayf, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PHCL 191

Identifier Type: -

Identifier Source: org_study_id

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