Resveratrol as a Preventive Treatment of OHSS

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Resveratrol; Drug: Placebo

• Registration Number: NCT03446625
• Lead Sponsor: IVI Madrid

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

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-27
• Study Start: 2018-03-13
• Status Verified: 2018-08
• Primary Completion: 2018-10-01
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Placebo	Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.
Control	Placebo	Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering.
Control	Resveratrol	Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering.
Resveratrol	Resveratrol	Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.

Primary Outcome Measures

Name	Time	Method
Serum VEGF levels	1 day	Serum determination of VEGF levels

Secondary Outcome Measures

Name	Time	Method
Hemoconcentration	1 day	Volume of red blood cells measured in percentage
Ascitis	1 day	Volume of liquid in Douglas pouch asessed in mililiters
Serum estradiol levels	1 day	Serum determination of estradiol levels asessed in picograms per mililiter

Trial Locations

Locations (1)

Ivi Madrid; 🇪🇸 Madrid, Spain