Infertility, Female
Conditions
Brief 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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTResveratrol
mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6
DIETARY_SUPPLEMENTFolic acid
400 mcg of folic acid
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
parallel, single blind, grouped randomised, interventional clinical study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gonadotropins IU | 6 months | dosage of gonadotropins (total IU during ovarian stimulation) |
| MII oocytes | 6 months | percentage of metaphase II oocytes |
| fertilization | 6 months | fertilization rates |
| embryos | 6 months | number of embryos |
| blastocysts | 6 months | number of blastocysts |
| gonadotropins days | 6 months | duration of ovarian stimulation (days) |
| follicles | 6 months | Number of follicles \>16 mm |
| oocytes | 6 months | number of recovered oocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| implantation | 18 months | Implantation rate |
| pregnancy | 18 months | clinical pregnancy rate |
| live birth | 18 months | live birth rate |
| miscarriage | 18 months | miscarriage rate |
| embryos number | 18 months | number of embryos per transfer |
Countries
Italy
Outcome results
None listed