Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
Sponsor
Rambam Health Care Campus (Other)
Overall Status
Unknown status
CT.gov ID
NCT03978013
Collaborator
(none)
40
2
27
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RCTRCT
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
Anticipated Study Start Date
:
Sep 1, 2019
Anticipated Primary Completion Date
:
Dec 1, 2020
Anticipated Study Completion Date
:
Dec 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pomegranate
|
Other: Pomegranate juice
Pomegranate juice
|
| Active Comparator: Apple
|
Other: Apple juice
Apple juice
|
Outcome Measures
Primary Outcome Measures
- Cytokines levels in follicle fluid [2 weeks]
Cytokines (pg/mL) will be mesured by elisa.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rambam Health Care Campus
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ola Gutzeit MD,
Principal Investigator,
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT03978013
Other Study ID Numbers:
- 017319
First Posted:
Jun 6, 2019
Last Update Posted:
Jun 6, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: