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

August 19, 2019 updated by: Juan A Garcia-Velasco, IVI Madrid

Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome

Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • IVI Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Resveratrol
Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.
Drug: Resveratrol
Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Other Names:
  • Resverasor Plus
Drug: Placebo
Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
PLACEBO_COMPARATOR: Control
Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering.
Drug: Resveratrol
Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
Other Names:
  • Resverasor Plus
Drug: Placebo
Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum VEGF levels
Time Frame: 1 day
Serum determination of VEGF levels
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoconcentration
Time Frame: 1 day
Volume of red blood cells measured in percentage
1 day
Serum estradiol levels
Time Frame: 1 day
Serum determination of estradiol levels asessed in picograms per mililiter
1 day
Ascitis
Time Frame: 1 day
Volume of liquid in Douglas pouch asessed in mililiters
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2018

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

February 20, 2018

First Posted (ACTUAL)

February 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401-MAD-004-IO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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