Biological Effects of Treatment With Resveratrol in ART Patients

University Of Perugia

Status: Completed

Conditions: Infertility, Female

Treatments: Dietary Supplement: Resveratrol; Dietary Supplement: Folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04386499

SR001

Details and patient eligibility

About

To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark GENANTE) on gamete quality in order to improve the reproductive process during ART.

Full description

The purpose of the study is to evaluate the effect of a new nutraceutical formulation containing resveratrol (trademark Genante) on gamete quality in order to improve the reproductive protocols during Assisted reproductive technology (ART) protocols.

The study is a randomized, single blind, parallel, comparative, experimental study during the pre-treatment before in vitro fertilization-embryo transfer (IVF-ET). A total number of 100 patients will be enrolled: 50 patients with a pretreatment control group (control group) and 50 patients with experimental pretreatment study group (resveratrol group). Patients will be assigned to groups during the recruitment phase in a randomized manner. In the control group, the treatment will consist of taking 400 microg once a day of folic acid commonly suggested as part of clinical practice, while in the Resveratrol Group, patients will receive one tablet twice a day (two tablets/day) of Genante. It is specified that the pretreatment with Genante includes folic acid in accordance with the clinical practice, 400 total microg per day. Both treatments will last for 3 months before the IVF procedure.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with a diagnosis of infertility
• BMI between 18 and 30 kg/m2,
• regular uterine cavity
• normal thyroid function
• normal blood parameters

Exclusion criteria

• primary or secondary ovarian failure
• patients who adhered to Bologna Criteria (at least two of the following: advanced maternal age >40, less than 3 oocytes recovered in previous attempts, abnormal ovarian reserve test)
• presence of ovaries inaccessible to the oocyte pick-up,
• persistent ovarian cysts > 20 mm,
• presence of sactosalpinx
• heterologous fertilization, significant systemic disease or other situations unsuitable for ovarian stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Resveratrol

Experimental group

Description:

A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D

Treatment:

Dietary Supplement: Resveratrol

Folic acid

Active Comparator group

Description:

Folic Acid 400 ug

Treatment:

Dietary Supplement: Folic acid