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Completed

NCT Number: NCT04386499

Biological Effects of Treatment With Resveratrol in ART Patients

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.

Perugia, Umbria, 06156, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6

Other names: Genante (S&R Farmaceutici S.p.A, Italy)

Folic Acid

Dietary Supplement

400 mcg of folic acid

Primary outcomes

  1. follicles

    Time frame: 6 months

    Number of follicles >16 mm

  2. oocytes

    Time frame: 6 months

    number of recovered oocytes

  3. MII oocytes

    Time frame: 6 months

    percentage of metaphase II oocytes

  4. fertilization

    Time frame: 6 months

    fertilization rates

  5. embryos

    Time frame: 6 months

    number of embryos

  6. blastocysts

    Time frame: 6 months

    number of blastocysts

  7. gonadotropins days

    Time frame: 6 months

    duration of ovarian stimulation (days)

  8. gonadotropins IU

    Time frame: 6 months

    dosage of gonadotropins (total IU during ovarian stimulation)

Secondary outcomes

  1. embryos number

    Time frame: 18 months

    number of embryos per transfer

  2. implantation

    Time frame: 18 months

    Implantation rate

  3. pregnancy

    Time frame: 18 months

    clinical pregnancy rate

  4. live birth

    Time frame: 18 months

    live birth rate

  5. miscarriage

    Time frame: 18 months

    miscarriage rate

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Official study title

Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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