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Resveratrol as a Preventive Treatment of OHSS (RES-OHSS)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
IVI Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility focused on measuring resveratrol, OHSS, PCOS

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Number of follicles greater than 12 mm after ovarian stimulation
  • Number of retrieved oocytes greater than 21

Exclusion Criteria:

  • >35 years-old
  • PCOS
  • Endometriosis
  • Systemic pathology
  • Positive serologies for HBV, HBC and HIV
  • Abnormal karyotype

Sites / Locations

  • Ivi Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol

Control

Arm Description

Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.

Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering.

Outcomes

Primary Outcome Measures

Serum VEGF levels
Serum determination of VEGF levels

Secondary Outcome Measures

Hemoconcentration
Volume of red blood cells measured in percentage
Serum estradiol levels
Serum determination of estradiol levels asessed in picograms per mililiter
Ascitis
Volume of liquid in Douglas pouch asessed in mililiters

Full Information

First Posted
January 12, 2017
Last Updated
August 19, 2019
Sponsor
IVI Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03446625
Brief Title
Resveratrol as a Preventive Treatment of OHSS
Acronym
RES-OHSS
Official Title
Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IVI Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors
Detailed Description
Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving hemoconcentration and symptomathology of this condition

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
resveratrol, OHSS, PCOS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Experimental
Arm Description
Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering.
Intervention Type
Drug
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
Resverasor Plus
Intervention Description
Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Primary Outcome Measure Information:
Title
Serum VEGF levels
Description
Serum determination of VEGF levels
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Hemoconcentration
Description
Volume of red blood cells measured in percentage
Time Frame
1 day
Title
Serum estradiol levels
Description
Serum determination of estradiol levels asessed in picograms per mililiter
Time Frame
1 day
Title
Ascitis
Description
Volume of liquid in Douglas pouch asessed in mililiters
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Number of follicles greater than 12 mm after ovarian stimulation Number of retrieved oocytes greater than 21 Exclusion Criteria: >35 years-old PCOS Endometriosis Systemic pathology Positive serologies for HBV, HBC and HIV Abnormal karyotype
Facility Information:
Facility Name
Ivi Madrid
City
Madrid
ZIP/Postal Code
28023
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22719052
Citation
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.
Results Reference
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PubMed Identifier
22959450
Citation
Ortega 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.
Results Reference
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PubMed Identifier
20140899
Citation
Basini 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.
Results Reference
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Resveratrol as a Preventive Treatment of OHSS

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