Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT06481696

Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility

Led by Andros Day Surgery Clinic · Updated on 2024-07-01

90

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 per WHO guidelines
  • Normal male genital anatomy by ultrasound
  • Normal male hormone levels (FSH, LH, Prolactin, Total Testosterone, Estradiol)
  • Bilateral tubal patency confirmed by 3-D HyFoSy or HSG
  • Normal uterine cavity confirmed by 3-D HyFoSy, HSG, or hysteroscopy
  • Absence of Anti-Chlamydia Trachomatis IgG/IgM antibodies
  • Failed intrauterine inseminations or decision not to undergo inseminations
Not Eligible

You will not qualify if you...

  • Smoking 15 or more cigarettes per day by either partner
  • Irregular menstrual cycles
  • Poor ovarian response based on Bologna criteria
  • Inaccessible ovaries
  • Severe endometriosis (stage III-IV ASRM classification)
  • Significant systemic diseases
  • Use of donated sperm (heterologous fertilization)
  • Previous pelvic surgery
  • Presence of ovarian cysts
  • Polycystic ovary syndrome
  • Use of hormonal contraception in the past 3 months
  • Use of gonadotrophins in the past 3 months
  • Stage III varicocele

AI-Screening

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Trial Site Locations

Total: 1 location

1

ANDROS Day Surgery Clinic

Palermo, Italy, 90144

Actively Recruiting

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Research Team

A

Adolfo Allegra, MD

CONTACT

A

Angelo Marino, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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