Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 6, 2019
June 1, 2019
1.3 years
June 2, 2019
June 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Cytokines levels in follicle fluid
Cytokines (pg/mL) will be mesured by elisa.
2 weeks
Study Arms (2)
Pomegranate
EXPERIMENTALApple
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients undergo IVF treatment with diagnosis of PCOS/Endometriosis/MF or AMA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Pomegranate and control juice will be provided by Primor Company, Hadera, Israel. Control juice has similar color and test but do not include pomegranate.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 2, 2019
First Posted
June 6, 2019
Study Start
September 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
June 6, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE