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NCT03446625 Clinical Trial

Resveratrol as a Preventive Treatment of OHSS

Infertility Clinical Trial

— RES-OHSS  

Official title:
Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03446625
Other study ID # 1401-MAD-004-IO
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 13, 2018
Est. completion date June 1, 2019

Study information
Verified date August 2018
Source IVI Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date June 1, 2019
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Spain Ivi Madrid Madrid

Sponsors (1)
Lead Sponsor Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Serum VEGF levels Serum determination of VEGF levels 1 day
Secondary Hemoconcentration Volume of red blood cells measured in percentage 1 day
Secondary Serum estradiol levels Serum determination of estradiol levels asessed in picograms per mililiter 1 day
Secondary Ascitis Volume of liquid in Douglas pouch asessed in mililiters 1 day
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