An interventional study of Standardized Mediterranean Diet and Gazpacho in Male Infertility, Oxidative Stress and Subfertility, sponsored by Ginefiv. Recruiting at 1 site in Spain. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Ginefiv · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether drinking a daily serving of gazpacho can improve semen quality in men with reduced sperm quality. The study will also examine how this dietary intervention affects oxidative stress and whether it is well tolerated.
The main questions this study aims to answer are:
Researchers will compare a Mediterranean diet plus daily gazpacho intake with a Mediterranean diet alone to determine whether adding gazpacho provides additional benefits for male reproductive health.
Participants will:
Detailed Description
This is a single-center, prospective, randomized, open-label, parallel-group study conducted at GINEFIV (IVIRMA Madrid). Eligible participants are men aged 18-45 years with an andrological profile that includes altered semen parameters such as oligozoospermia with or without associated asthenozoospermia and/or teratozoospermia (O±A±T). Participants will be randomized in a 1:1 ratio to a control group following a standardized Mediterranean diet or an intervention group following the same diet with the addition of 330 mL per day of commercially available gazpacho.
The intervention period lasts 12 weeks. Participants in the intervention group will consume gazpacho once daily with a main meal. Two production batches of the product will be analyzed to determine lycopene, vitamin C, and vitamin E content. Adherence to the intervention will be evaluated using a self-administered compliance diary and scheduled follow-up phone calls.
Semen samples will be collected at baseline and at the end of the intervention period. Semen analysis will be performed according to World Health Organization (WHO) 2021 guidelines. Seminal oxidative stress will be assessed using the OxiSperm II test and its Research Use Only (RUO) digital application, which will not be used for clinical decision-making.
The primary objective of the study is to evaluate changes in semen quality following the intervention. Secondary objectives include the assessment of seminal oxidative stress, adherence to the dietary intervention, safety and tolerability, and reproductive outcomes collected during post-intervention follow-up.
Participants will be followed for 18 months after completion of the intervention to record reproductive outcomes. The total study duration is estimated at 54 months, including recruitment, intervention, follow-up, and data analysis periods.
Exclusion Criteria:
Participants will follow a standardized Mediterranean diet for a period of 12 weeks. Adherence to the dietary recommendations will be monitored using a self-administered compliance diary and scheduled follow-up phone calls.
Other: Standardized Mediterranean Diet
Participants assigned to the intervention arm will follow a standardized Mediterranean diet for 12 weeks and will additionally consume 330 mL of commercially available gazpacho once daily with a main meal. Adherence to the intervention will be monitored using a self-administered compliance diary and scheduled follow-up phone calls.
Other: Standardized Mediterranean Diet · Dietary Supplement: Gazpacho
Participants will follow a standardized Mediterranean diet for a period of 12 weeks. The dietary pattern emphasizes the consumption of vegetables, fruits, legumes, whole grains, olive oil as the main source of fat, moderate intake of fish and nuts, and limited intake of red and processed meats.
Participants will consume 330 mL per day of commercially available gazpacho, taken once daily with a main meal, for a period of 12 weeks. The gazpacho will be consumed as part of the daily diet in addition to a standardized Mediterranean diet.
Change in Ejaculate Volume (mL)
Semen volume measured according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Time frame: Baseline to 12 weeks
Change in Sperm Concentration (million/mL)
Sperm concentration measured according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Time frame: Baseline to 12 weeks
Change in Total Sperm Motility (%)
Percentage of motile spermatozoa (total motility) assessed according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Time frame: Baseline to 12 weeks
Change in Progressive Sperm Motility (%)
Percentage of progressively motile spermatozoa assessed according to WHO 2021 semen analysis guidelines. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Time frame: Baseline to 12 weeks
Change in Normal Sperm Morphology (%)
Percentage of spermatozoa with normal morphology assessed according to WHO 2021 criteria. This outcome will be analyzed and reported as an independent measure of semen quality. No composite or aggregated semen analysis score will be calculated; each parameter will be reported separately as a standalone outcome.
Time frame: Baseline to 12 weeks
Change in Seminal Oxidative Stress Signal (Color Units, CU)
Seminal oxidative stress assessed using the OxiSperm II test based on a nitroblue tetrazolium (NBT) colorimetric reaction. The OXI II application provides a digital quantitative output expressed in Color Units (CU), ranging from 0 to 100 CU which will be reported as a continuous variable.
Time frame: Baseline to 12 weeks
Adherence to Gazpacho Intake (%)
Percentage of planned gazpacho intakes completed during the 12-week intervention period, assessed using a self-administered compliance diary and scheduled follow-up phone calls.
Time frame: Baseline to12 weeks
Incidence of Treatment-Emergent Adverse Events
Number and type of adverse events reported by participants during the 12-week dietary intervention period, assessed through participant self-report and scheduled follow-up phone calls.
Time frame: Baseline to 12 weeks
Biochemical Pregnancy Rate
Proportion of female partners with at least one positive serum or urinary hCG test during the follow-up period, calculated as the number of participants with a biochemical pregnancy divided by the total number of participants at risk.
Time frame: Up to 18 months post-intervention
Clinical Pregnancy Rate
Proportion of female partners with an ultrasound-confirmed intrauterine pregnancy during the follow-up period, calculated as the number of participants with a clinical pregnancy divided by the total number of participants at risk.
Time frame: Up to 18 months post-intervention
Miscarriage Rate
Proportion of clinically confirmed pregnancies that result in pregnancy loss, calculated as the number of miscarriages divided by the total number of clinical pregnancies.
Time frame: Up to 18 months post-intervention
Live Birth Rate
Proportion of pregnancies resulting in a live-born infant, calculated as the number of live births divided by the total number of clinical pregnancies.
Time frame: Up to 18 months post-intervention
Plan to share: No — Individual participant data will not be shared with external researchers. The study involves sensitive reproductive health data, and there is no predefined plan for public data sharing. Data may be processed by authorized technical partners for analytical purposes under confidentiality agreements, in compliance with applicable data protection regulations.
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