NCT03978013

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 2, 2019

Last Update Submit

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

EXPERIMENTAL
Other: Pomegranate juice

Apple

ACTIVE COMPARATOR
Other: Apple juice

Interventions

Pomegranate juice

Pomegranate

Apple juice

Apple

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

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
Model Details: RCT
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