Back to resultsPomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Primary Purpose
PCOS, Endometriosis, Advised Maternal Age
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pomegranate juice
Apple juice
Sponsored by
About this trial
This is an interventional supportive care trial for PCOS
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pomegranate
Apple
Arm Description
Outcomes
Primary Outcome Measures
Cytokines levels in follicle fluid
Cytokines (pg/mL) will be mesured by elisa.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03978013
Brief Title
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Official Title
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Endometriosis, Advised Maternal Age, Male Factor Infertility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pomegranate
Arm Type
Experimental
Arm Title
Apple
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pomegranate juice
Intervention Description
Pomegranate juice
Intervention Type
Other
Intervention Name(s)
Apple juice
Intervention Description
Apple juice
Primary Outcome Measure Information:
Title
Cytokines levels in follicle fluid
Description
Cytokines (pg/mL) will be mesured by elisa.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
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