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Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

Primary Purpose

Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
vitamin E
Metformin
Clomiphene Citrate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clomiphene Citrate Resistant Polycystic Ovary Syndrome focused on measuring Vitamin E, Polycystic ovary

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center of Infertility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vitamin E group

control group

Arm Description

30 patient

clomiphene

Outcomes

Primary Outcome Measures

ovulation rate
Follicles measure more than 18 mm will be considered mature follicles.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2018
Last Updated
July 8, 2020
Sponsor
Ain Shams University
Collaborators
Misr University for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03674385
Brief Title
Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate
Official Title
Evaluation of the Clinical Outcome of Vitamin E as Adjuvant Therapy in Patients With Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Misr University for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Keywords
Vitamin E, Polycystic ovary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled open label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin E group
Arm Type
Experimental
Arm Description
30 patient
Arm Title
control group
Arm Type
Active Comparator
Arm Description
clomiphene
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin E
Other Intervention Name(s)
toco 1000
Intervention Description
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
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
cidophage
Intervention Description
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
Intervention Name(s)
Clomiphene Citrate
Other Intervention Name(s)
clomid
Intervention Description
is a medication used to treat infertility in women who do not ovulate
Primary Outcome Measure Information:
Title
ovulation rate
Description
Follicles measure more than 18 mm will be considered mature follicles.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical Center of Infertility
City
Banī Suwayf
ZIP/Postal Code
62521
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

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