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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978013
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
PCOS Endometriosis Advised Maternal Age Male Factor Infertility Other: Pomegranate juice Other: Apple juice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Pomegranate Other: Pomegranate juice
Pomegranate juice

Active Comparator: Apple Other: Apple juice
Apple juice




Primary Outcome Measures :
  1. Cytokines levels in follicle fluid [ Time Frame: 2 weeks ]
    Cytokines (pg/mL) will be mesured by elisa.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Ola Gutzeit MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03978013    
Other Study ID Numbers: 017319
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Endometriosis
Genital Diseases, Male
Genital Diseases, Female