Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate
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ClinicalTrials.gov Identifier: NCT03674385 |
Recruitment Status :
Completed
First Posted : September 17, 2018
Last Update Posted : July 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clomiphene Citrate Resistant Polycystic Ovary Syndrome | Dietary Supplement: vitamin E Drug: Metformin Drug: Clomiphene Citrate | Phase 2 |
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 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 |

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

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Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674385
Egypt | |
Medical Center of Infertility | |
Banī Suwayf, Egypt, 62521 |
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 Key Record Dates |
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 |
Vitamin E Polycystic ovary |
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 |