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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D |
|
| Folic acid | Active Comparator | Folic Acid 400 ug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Dietary Supplement | mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| follicles | Number of follicles >16 mm | 6 months |
| oocytes | number of recovered oocytes | 6 months |
| MII oocytes | percentage of metaphase II oocytes | 6 months |
| fertilization | fertilization rates | 6 months |
| embryos | number of embryos | 6 months |
| blastocysts | number of blastocysts | 6 months |
| gonadotropins days | duration of ovarian stimulation (days) | 6 months |
| gonadotropins IU | dosage of gonadotropins (total IU during ovarian stimulation) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| embryos number | number of embryos per transfer | 18 months |
| implantation | Implantation rate | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Sandro Gerli, MD | University Of Perugia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte. | Perugia | Umbria | 06156 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34338114 | Derived | Gerli S, Della Morte C, Ceccobelli M, Mariani M, Favilli A, Leonardi L, Lanti A, Iannitti RG, Fioretti B. Biological and clinical effects of a resveratrol-based multivitamin supplement on intracytoplasmic sperm injection cycles: a single-center, randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):7640-7648. doi: 10.1080/14767058.2021.1958313. Epub 2021 Aug 1. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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parallel, single blind, grouped randomised, interventional clinical study
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| Folic acid | Dietary Supplement | 400 mcg of folic acid |
|
| pregnancy | clinical pregnancy rate | 18 months |
| live birth | live birth rate | 18 months |
| miscarriage | miscarriage rate | 18 months |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |