Randomized, Placebo-controlled, Double-blind, Single-center Trial to Evaluate the Possible Action of Resveratrol in Improving the Outcomes of Controlled Ovarian Stimulation During the IVF/ICSI Cycles in Couples With Unexplained Infertility

ANDROS-01-24

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.

2024-06-01

2025-12-31

2025-12-31

Recruiting

90

Inclusion Criteria: * Female age 18-40 years * Female BMI 18-30 kg/m2 * normal menstrual cycles (26-35 days) * duration of infertility at least 18 months * normal semen parameters as established by WHO laboratory manual for the examination and processing of human semen Sixth edition * normal US evaluation of male genital anatomy * normal FSH, LH, Prolactin, Total Testosterone, Estradiol in male partner * bilateral tubal patency established by 3-D HyFoSy or HSG * normal uterine cavity evaluated by 3-D HyFoSy or HSG or hysteroscopy * absence of antibodies Anti-Chlamyidia Trachomatis IgG/IgM * failed intrauterine inseminations or couple's decision to refuse intrauterine inseminations Exclusion Criteria: * ≥15 cigarettes per day at least in one of the partners * irregular menstrual cycles * poor ovarian response (on the basis of the "Bologna" Criteria) * inaccessible ovaries * severe endometriosis (stage III-IV of the ASRM revised classification) * significant systemic diseases * heterologous fertilization * previous pelvic surgery * presence of ovarian cysts * polycystic ovary syndrome * use of hormonal contraception in the previous 3 months * use of gonadotrophins in the previous 3 months * III stage varicocele

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2024-07-01