Resveratrol as a Preventive Treatment of OHSS
RES-OHSS
1 other identifier
interventional
70
1 country
1
Brief Summary
Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2018
Shorter than P25 for phase_3
1 active site
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
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2018
CompletedStudy Start
First participant enrolled
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 20, 2019
August 1, 2018
7 months
January 12, 2017
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum VEGF levels
Serum determination of VEGF levels
1 day
Secondary Outcomes (3)
Hemoconcentration
1 day
Serum estradiol levels
1 day
Ascitis
1 day
Study Arms (2)
Resveratrol
EXPERIMENTALResveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.
Control
PLACEBO COMPARATORPlacebo treatment will be administered for 9 days, starting on the day of ovulation triggering.
Interventions
Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Eligibility Criteria
You may qualify if:
- Number of follicles greater than 12 mm after ovarian stimulation
- Number of retrieved oocytes greater than 21
You may not qualify if:
- \>35 years-old
- PCOS
- Endometriosis
- Systemic pathology
- Positive serologies for HBV, HBC and HIV
- Abnormal karyotype
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVI Madridlead
Study Sites (1)
Ivi Madrid
Madrid, 28023, Spain
Related Publications (3)
Ortega I, Villanueva JA, Wong DH, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Resveratrol reduces steroidogenesis in rat ovarian theca-interstitial cells: the role of inhibition of Akt/PKB signaling pathway. Endocrinology. 2012 Aug;153(8):4019-29. doi: 10.1210/en.2012-1385. Epub 2012 Jun 19.
PMID: 22719052BACKGROUNDOrtega I, Wong DH, Villanueva JA, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Effects of resveratrol on growth and function of rat ovarian granulosa cells. Fertil Steril. 2012 Dec;98(6):1563-73. doi: 10.1016/j.fertnstert.2012.08.004. Epub 2012 Sep 6.
PMID: 22959450BACKGROUNDBasini G, Tringali C, Baioni L, Bussolati S, Spatafora C, Grasselli F. Biological effects on granulosa cells of hydroxylated and methylated resveratrol analogues. Mol Nutr Food Res. 2010 Jul;54 Suppl 2:S236-43. doi: 10.1002/mnfr.200900320.
PMID: 20140899BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 12, 2017
First Posted
February 27, 2018
Study Start
March 13, 2018
Primary Completion
October 1, 2018
Study Completion
June 1, 2019
Last Updated
August 20, 2019
Record last verified: 2018-08