Protocol summary
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Study aim
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Comparing the effect of Phlebotomy and Cyproterone Compound on insulin resistance, anti-mullerian hormone, and Prostatic Specific Antigen (PSA) concentrations in patients with PCOS
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Design
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After obtaining informed consent, the 120 included patients were randomly allocated in a 1:1 ratio to either the iron-reduction group of phlebotomy and the cyproterone compound group , using a random number table. they didn't received any medication.
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Settings and conduct
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All refereed PCOS patients to Endocrine clinic, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences were randomly allocated to phlebotomy and CC groups. Phlebotomy Patients undergo venesection of 450 ml of whole blood and are advised not to use any hormonal or iron- containing medications. Cyproterone Compound group were advised three cycles of pills are prescribed. Each cycle includes 21 days of use and 7 days without pills. They should not use any other medications (e.g. hormone(s) or Iron-containing drugs).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: PCOS pateints with: 18-45 years old; Hgb more than 12; ferritine more than 20; no diabetes melitus ; no heart problem; no hypertention or under treatment; not pregnant;no thyroid problem; no cancer. Exclusion criteria: pregnancy; heart or thyroid disease; hypertntion; cancer; diabetes melitus.
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Intervention groups
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RCT will be performed in two groups: The study group was undergone venesection of 450 mL of whole blood. The cyproteron compound group received Cyproterone Compound pill for 3 months from day 1 of spontaneous or progesterone-induced menstrual cycle onwards for 3 weeks and Followed by a pill-free interval of 7 days
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Main outcome variables
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Hirsutism score, HOMA-IR score
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2013080514277N1
Registration date:
2014-06-16, 1393/03/26
Registration timing:
prospective
Last update:
2018-12-14, 1397/09/23
Update count:
1
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Registration date
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2014-06-16, 1393/03/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shaheed Beheshti University of Medical Sciences
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Expected recruitment start date
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2014-06-22, 1393/04/01
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Expected recruitment end date
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2015-06-22, 1394/04/01
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Actual recruitment start date
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2014-06-22, 1393/04/01
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Actual recruitment end date
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2016-03-20, 1395/01/01
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Trial completion date
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2016-03-20, 1395/01/01
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Scientific title
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Comparison of phlebothomy and Cyproterone compound in insulin resistance, antimullerian hormone(AMH) and prostatic specific antigen(PSA) in polycystic ovarian syndrome patients
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Public title
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Phelebothomy in polycystic ovarian syndrome (PCOS)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
PCOS patients
18-45 years old
Hgb more than 12
ferritine more than 20
free of diabetes melitus
free of heart disease
free of hypertension
free of cancer
free of thyroid problem
Exclusion criteria:
pregnancy
ِDiabetes
Cardiovascular disease
Hypertension
Thyroid disease
cancer
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation using random number table will be performed
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-02-26, 1391/12/08
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Ethics committee reference number
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17ECRIES91/12/08
Health conditions studied
1
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Description of health condition studied
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polycystic ovarian syndrom
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Insulin resistance with Homeostatic Model Assessment (HOMA-IR)
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Timepoint
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Before intervention and immediately after intervention (3 month)
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Method of measurement
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Laboratory
2
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Description
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Anti mullerian hormone
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Timepoint
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Before intervention and immediately after intervention (3 month)
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Method of measurement
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Laboratory assessment
3
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Description
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Prostate-Specific Antigen
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Timepoint
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Before intervention and immediately after intervention (3 month)
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Method of measurement
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Laboratory
Secondary outcomes
1
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Description
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Hirsutism Score
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Timepoint
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Before intervention and immediately after intervention (3 month)
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Method of measurement
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clinical
2
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Description
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Menstural irregularity
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Timepoint
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Before intervention and immediately after intervention (3 month)
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Method of measurement
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Questionair
Intervention groups
1
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Description
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Intervention group (Phlebotomy group): Patients undergo venesection of 450 ml of whole blood and are advised not to use any hormonal or iron- containing medications.
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Category
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Treatment - Other
2
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Description
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Control group: patient who randomly allocated in control group, will be received the 1 tab of cyproteron compound for 21 days (with 7 days free of tab) for 3 cycles.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Institute for Endocrine Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The participant data file will be encoded and will be used for final analysis. The research results will be published in the form of a paper
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When the data will become available and for how long
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The participant data file will be available 6 months after publishing the final paper
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To whom data/document is available
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Data will be available to researchers that working in academic institutions
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Under which criteria data/document could be used
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The names and contact numbers of the participants in the study are confidential. Other information will be available.
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From where data/document is obtainable
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Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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What processes are involved for a request to access data/document
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The applicant must complete the application form by attending the application
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Comments
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