Using resveratrol to improve IVF outcomes for couples with unexplained infertility
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
This study is testing if taking a resveratrol supplement can help improve IVF success rates for couples dealing with unexplained infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Andros Day Surgery Clinic Academic / other |
| Locations | 1 site (Palermo) |
| Trial ID | NCT06481696 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of resveratrol supplementation on the biological and clinical outcomes of women undergoing IVF/ICSI for unexplained infertility. It is a randomized, controlled, double-blind, single-center trial designed to assess whether resveratrol can enhance oocyte quality and improve pregnancy rates. The study aims to address the unexplained aspects of infertility by focusing on the processes of folliculogenesis and oocyte maturation, which are not routinely examined. Participants will receive a resveratrol-based multivitamin supplement alongside standard IVF/ICSI treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 with a BMI of 18-30 and a history of unexplained infertility lasting at least 18 months.
Not a fit: Patients with irregular menstrual cycles, severe endometriosis, or significant systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option that improves IVF outcomes for couples facing unexplained infertility.
How similar studies have performed: To date, no studies have published results on the effects of resveratrol on IVF/ICSI outcomes in couples with unexplained infertility, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palermo
- ANDROS Day Surgery Clinic — Palermo, Italy (Recruiting)
Study contacts
- Principal investigator: Adolfo Allegra, MD — ANDROS Day Surgery Clinic Palermo, Italy
- Study coordinator: Adolfo Allegra, MD
- Email: adolfo.allegra@clinicaandros.it
- Phone: 0039 091 6785535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.