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RES-OHSS: Resveratrol as a Preventive Treatment of OHSS

Sponsor
IVI Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT03446625
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
14.6
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome
Actual Study Start Date :
Mar 13, 2018
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Serum VEGF levels [1 day]

      Serum determination of VEGF levels

    Secondary Outcome Measures

    1. Hemoconcentration [1 day]

      Volume of red blood cells measured in percentage

    2. Serum estradiol levels [1 day]

      Serum determination of estradiol levels asessed in picograms per mililiter

    3. Ascitis [1 day]

      Volume of liquid in Douglas pouch asessed in mililiters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ivi Madrid Madrid Spain 28023

    Sponsors and Collaborators

    • IVI Madrid

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Juan A Garcia-Velasco, MD, IVI Madrid
    ClinicalTrials.gov Identifier:
    NCT03446625
    Other Study ID Numbers:
    • 1401-MAD-004-IO
    First Posted:
    Feb 27, 2018
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2018
    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
    Keywords provided by Juan A Garcia-Velasco, MD, IVI Madrid
    resveratrol
    OHSS
    PCOS
    Additional relevant MeSH terms:
    Infertility
    Resveratrol

    Study Results

    No Results Posted as of Aug 20, 2019