Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility
NCT Number: NCT06481696
Acronym: RECOS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Unexplained Infertility
Interventions: DIETARY_SUPPLEMENT: Resveratrol-based multivitamin supplement|DIETARY_SUPPLEMENT: Folic acid|PROCEDURE: IVF/ICSI|DRUG: Follitropin Alfa|DRUG: Ganirelix Acetate 0.5 MG/ML [Fyremadel]|DRUG: hCG 10.000 IU or triptorelin 0,3 mg, subcutaneously
Sponsor: Andros Day Surgery Clinic
Sex: FEMALE
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-12-31
Locations: ANDROS Day Surgery Clinic, Palermo, 90144, Italy

Summary:
Based on available evidence and given the potential beneficial effects of resveratrol in folliculogenesis and in oocyte development, the investigators designed a randomized, controlled, double-blind, single-center trial, whose objective will be the comparison of biological and clinical outcomes of resveratrol supplement in women undergoing IVF/ICSI cycles for unexplained infertility.

To the knowledge of the investigators, no study has been published on the potential effect of resveratrol on IVF/ICSI outcomes considering couples with this infertility diagnosis, which may be the natural target of this integrative treatment because the process of folliculogenesis and oocyte maturation cannot be routinely investigated. An alteration of these biological mechanisms could be the unrecognized cause of part of the unexplained infertility and treatment with resveratrol could result in significant clinical improvement for the patients enrolled in the study.

In more details, the main objective of this randomized, placebo-controlled, double-blind, single-center trial will be the evaluation of the possible effect of resveratrol in determining a better follicle development in patients with unexplained infertility undergoing controlled ovarian stimulation (COS) for IVF/ICSI.

Infertile female patients with normal ovarian reserve will be treated according to clinical practice and the difference between expected (through AFC) and retrieved oocytes will be assessed in relation to use of resveratrol.

Primary Outcome Measures: FORT (Follicle Output Rate), It is defined as the ratio of pre-ovulatory follicle (≥ 16 mm in diameter) count (PFC) on the day of induction of oocyte maturation and the antral follicle count at baseline, multiplied by 100 (higher values indicate a better outcome)., The assessment will be performed at the end of stimulation (11°-15° day of a menstrual cycle of 28 days)|FOI (Follicle to Oocyte Index), It is defined by the ratio between the total number of oocytes collected at oocyte pick up and the number of antral follicles at baseline, multiplied by 100. FOI ≤ 50% is considered low (range 0-100%)., The assessment will be performed at the end of oocyte pick up (2 hours after the oocyte pick up)|The number of mature oocytes, The number of oocytes which have completed the metaphase-II division, The assessment will be performed after the oocyte pick up (2 hours after the oocyte pick up)|OSI (Ovarian Sensitivity Index), It is defined by the ratio between the number of retrieved oocytes and total dose of gonadotropins administered, multiplied by 1000., The assessment will be performed at the end of oocyte pick up (2 hours after the oocyte pick up)
Secondary Outcome Measures: Fertilization rate, The number of embryos obtained after the oocyte insemination., The assessment will be carried out the day after the insemination (one day after the oocyte pick up).|Cumulative Clinical Pregnancy Rate, It is defined by the ratio between the number of clinical pregnancies (gestational sacs with a fetal heartbeat detected at ultrasound at 7th week of amenorrhea) and the total number of embryo transfers (fresh + frozen) carried out per each patient., The assessment will be carried out at 7th week of amenorrhea.