Resveratrol as a Preventive Treatment of OHSS

NCT ID: NCT03446625

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2019-06-01

Brief Summary

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Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Detailed Description

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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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Resveratrol

Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering.

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Resveratrol

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Resveratrol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Resverasor Plus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Juan A Garcia-Velasco

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ivi Madrid

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22719052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22959450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20140899 (View on PubMed)

Other Identifiers

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1401-MAD-004-IO

Identifier Type: -

Identifier Source: org_study_id

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