Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate
NCT ID: NCT03674385
Last Updated: 2020-07-10
Study Results
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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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2018-07-19
2019-03-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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vitamin E group
30 patient
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
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
control group
clomiphene
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
39 Years
FEMALE
No
Sponsors
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Misr University for Science and Technology
OTHER
Ain Shams University
OTHER
Responsible Party
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Ahmed Abbas Morsy Morsy
pharmacist
Locations
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Medical Center of Infertility
Banī Suwayf, , Egypt
Countries
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Other Identifiers
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PHCL 191
Identifier Type: -
Identifier Source: org_study_id
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