Effects of Resveratrol Supplementation on Oocyte Quality

NCT06235294 | Unknown

• 1 other identifier: RA-01-23
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to verify if 3-month oral supplementation with resveratrol can enhance the oocyte quality in advanced maternal age women undergoing in vitro fertilization (IVF). Participants will take a daily capsule of resveratrol or placebo during the 3 months preceding their IVF treatment. They will then follow the same treatment protocol as non-participant patients.

Conditions

Aging; Infertility

Keywords

in vitro fertilization; oocyte quality; resveratrol

Outcome Measures

Primary Outcomes (1)

• Number of good-quality embryos

  Embryos available to transfer or cryopreservation.

  4 months

Secondary Outcomes (8)

• Number of oocytes and mature oocytes

  4 months

• Fertilization rate

  4 months

• Cleavage rate

  4 months

• Biochemical pregnancy rate

  up to 15 months

• Clinical pregnancy rate per cycle

  up to 15 months

Study Arms (2)

Resveratrol

EXPERIMENTAL

Daily capsule of 200 mg Polygonum cuspidatum yielding 100 mg/day resveratrol (trans-3,5,4'-trihydroxystilbene)

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Daily capsule of 400 mcg folic acid.

Dietary Supplement: Folic acid

Interventions

Resveratrol DIETARY_SUPPLEMENT

Daily capsule of 200 mg Polygonum cuspidatum (Solgar®, Dietimport, Lisboa, Portugal) yielding 100 mg/day resveratrol (trans-3,5,4'-trihydroxystilbene), by morning, every day during the 3 months preceding in vitro fertilization treatment.

Resveratrol

Folic acid DIETARY_SUPPLEMENT

Daily capsule of 400 mcg folic acid (Solgar®, Dietimport, Lisboa, Portugal), by morning, every day during the 3 months preceding in vitro fertilization treatment.

Placebo

Eligibility Criteria

• Age: 35 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with infertility undergoing IVF/ICSI
• Ovarian stimulation with GnRH-antagonist protocol
• Age 35-40 years old

You may not qualify if:

• Severe male factor (oligospermia or azoospermia)
• Low ovarian reserve (AMH \< 1.1. ng/mL)
• Poor response to ovarian stimulation (\< 3 oocytes)
• Polycystic ovarian syndrome (Rotterdam criteria)
• Ovarian endometriosis (endometrioma \> 30 mm)
• Uterine anomalies (congenital or acquired)
• Diabetes Mellitus
• Concurrent use of any vitamin (except folic acid)

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

MeSH Terms

Conditions

Infertility

Interventions

Resveratrol; Folic Acid

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients, physicians, and embryologists will be blinded to group assignments of the participants in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to groups according to random numbers generated by a computer and implemented via a sealed envelope. The random allocation, enrollment of patients and assignment of intervention will be performed by the principal investigator.

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 31, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01