Biological Effects of Treatment With Resveratrol in ART Patients

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386499
• Other study ID #: SR001
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: May 2020
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 5, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Dietary Supplement:
• Resveratrol
mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6
• Folic acid
400 mcg of folic acid

Locations

Country	Name	City	State
Italy	University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.	Perugia	Umbria

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follicles	Number of follicles >16 mm	6 months
Primary	oocytes	number of recovered oocytes	6 months
Primary	MII oocytes	percentage of metaphase II oocytes	6 months
Primary	fertilization	fertilization rates	6 months
Primary	embryos	number of embryos	6 months
Primary	blastocysts	number of blastocysts	6 months
Primary	gonadotropins days	duration of ovarian stimulation (days)	6 months
Primary	gonadotropins IU	dosage of gonadotropins (total IU during ovarian stimulation)	6 months
Secondary	embryos number	number of embryos per transfer	18 months
Secondary	implantation	Implantation rate	18 months
Secondary	pregnancy	clinical pregnancy rate	18 months
Secondary	live birth	live birth rate	18 months
Secondary	miscarriage	miscarriage rate	18 months