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Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment

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ClinicalTrials.gov Identifier: NCT03978013
Recruitment Status : Unknown
Verified June 2019 by Ola Gutzeit MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ola Gutzeit MD, Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 6, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Cytokines levels in follicle fluid [ Time Frame: 2 weeks ]
Cytokines (pg/mL) will be mesured by elisa.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Official Title  ICMJE Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Brief Summary tTe investigators estimate pomegranate supplementation effect on oxidative stress in infertile women with PCOS, endometriosis and advanced maternal age during IVF treatment. The primary aim is to compare the obtained oxidative stress markers in follicular fluid with pomegranate supplementation vs control.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
RCT
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Pomegranate and control juice will be provided by Primor Company, Hadera, Israel. Control juice has similar color and test but do not include pomegranate.
Primary Purpose: Supportive Care
Condition  ICMJE
  • PCOS
  • Endometriosis
  • Advised Maternal Age
  • Male Factor Infertility
Intervention  ICMJE
  • Other: Pomegranate juice
    Pomegranate juice
  • Other: Apple juice
    Apple juice
Study Arms  ICMJE
  • Experimental: Pomegranate
    Intervention: Other: Pomegranate juice
  • Active Comparator: Apple
    Intervention: Other: Apple juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergo IVF treatment with diagnosis of PCOS/Endometriosis/MF or AMA

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria, as above
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978013
Other Study ID Numbers  ICMJE 017319
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Current Responsible Party Ola Gutzeit MD, Rambam Health Care Campus
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rambam Health Care Campus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rambam Health Care Campus
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP