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CompletedNCT03446625RES-OHSSUpdated Aug 20, 2019

Resveratrol as a Preventive Treatment of OHSS

A Phase 3 interventional study of Resveratrol and Placebo in Infertility, sponsored by IVI Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by IVI Madrid · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Read the 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

02

Conditions studied

  • Infertility

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Keywords

  • resveratrol
  • OHSS
  • PCOS
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

Exclusion Criteria:

  • >35 years-old
  • PCOS
  • Endometriosis
  • Systemic pathology
  • Positive serologies for HBV, HBC and HIV
  • Abnormal karyotype
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • 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 · Drug: Placebo

  • Placebo comparator
    Control

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

    Drug: Resveratrol · Drug: Placebo

Interventions

  • DrugResveratrol

    Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.

    Also known as: Resverasor Plus

  • DrugPlacebo

    Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.

05

What researchers measure

Primary outcomes

  1. Serum VEGF levels

    Serum determination of VEGF levels

    Time frame: 1 day

Secondary outcomes

  1. Hemoconcentration

    Volume of red blood cells measured in percentage

    Time frame: 1 day

  2. Serum estradiol levels

    Serum determination of estradiol levels asessed in picograms per mililiter

    Time frame: 1 day

  3. Ascitis

    Volume of liquid in Douglas pouch asessed in mililiters

    Time frame: 1 day

06

Study locations

1 site
  • Ivi Madrid
    Madrid, 28023, Spain
07

References and documents

Publications

  • 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. PubMed 22719052 ↗
  • 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. PubMed 22959450 ↗
  • 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. PubMed 20140899 ↗
08

Registry details

Key details

Study ID
NCT03446625
Lead sponsor
IVI Madrid
Responsible party
Juan A Garcia-Velasco (MD, IVI Madrid) — Principal investigator
First posted
Feb 27, 2018
Start date
Mar 13, 2018
Primary completion
Oct 1, 2018
Completion
Jun 1, 2019
Last update
Aug 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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