NCT07375238

Brief Summary

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:

  • Does daily consumption of gazpacho improve semen quality in men with altered semen parameters?
  • Does this dietary intervention affect levels of oxidative stress in semen?
  • Is daily gazpacho intake feasible and well tolerated as part of a Mediterranean diet? 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:
  • Follow a standardized Mediterranean diet for 12 weeks
  • Drink 330 mL of gazpacho every day or follow the diet without gazpacho
  • Provide semen samples at the start of the study and after 12 weeks
  • Complete a short diary to record adherence to the dietary intervention
  • Be followed for up to 18 months to record reproductive outcomes

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
39mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Sep 2029

First Submitted

Initial submission to the registry

January 13, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 13, 2026

Last Update Submit

March 11, 2026

Conditions

Male InfertilityOxidative StressSubfertilityOligozoospermiaTeratozoospermiaAsthenozoospermia

Keywords

Mediterranean dietGazpachosperm qualityMale infertilityAltered semen parametersoxidative stressOxiSperm IIRandomized trial

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline to 12 weeks

Secondary Outcomes (7)

  • Change in Seminal Oxidative Stress Signal (Color Units, CU)

    Baseline to 12 weeks

  • Adherence to Gazpacho Intake (%)

    Baseline to12 weeks

  • Incidence of Treatment-Emergent Adverse Events

    Baseline to 12 weeks

  • Biochemical Pregnancy Rate

    Up to 18 months post-intervention

  • Clinical Pregnancy Rate

    Up to 18 months post-intervention

  • +2 more secondary outcomes

Study Arms (2)

Standardized Mediterranean Diet Alone (Control)

ACTIVE COMPARATOR

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

Gazpacho + Standardized Mediterranean Diet (Intervention)

EXPERIMENTAL

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 DietDietary Supplement: Gazpacho

Interventions

GazpachoDIETARY_SUPPLEMENT

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.

Gazpacho + Standardized Mediterranean Diet (Intervention)
Standardized Mediterranean DietOTHER

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.

Gazpacho + Standardized Mediterranean Diet (Intervention)Standardized Mediterranean Diet Alone (Control)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18 to 45 years
  • Andrological profile including altered semen parameters such as oligozoospermia, asthenozoospermia and/or teratozoospermia (O±A±T)
  • No clinical indication for sperm DNA fragmentation testing or advanced sperm selection techniques
  • Willingness and ability to comply with the study protocol, including adherence to a standardized Mediterranean diet
  • Signed and dated written informed consent form

You may not qualify if:

  • Use of antioxidant supplements during the three months prior to study start.
  • Active smokers or men who have stopped smoking within the last three months.
  • Diagnosis of azoospermia, leucocytospermia or necrozoospermia.
  • Presence of severe systemic diseases or chronic conditions that could interfere with semen quality or adherence to the study.
  • Known allergy or intolerance to any ingredient of the gazpacho used in the study.
  • Any medical, psychological or social condition that, in the investigator's judgement, could compromise the subject's ability to participate fully or comply with the protocol requirements.
  • Simultaneous participation in another clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GINEFIV Madrid (IVIRMA Group)

Madrid, Madrid, 28010, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, MaleInfertilityOligospermiaAsthenozoospermiaTeratozoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Pablo Martí Pastor, RD, RND

    Ginefiv Madrid (IVIRMA Group)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Martí Pastor, RN, RDN

CONTACT

+34 669975090pablo.marti@ginefiv.com

Julio Gijón de la Santa, Senior Clinical Embryologist

CONTACT

636636799julio.gijon@ginefiv.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Due to the nature of the dietary intervention, masking of participants and care providers is not feasible. Laboratory personnel performing semen analysis and oxidative stress assessments are not involved in the allocation process and are blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned in a 1:1 ratio to either a control group following a standardized Mediterranean diet or an intervention group following the same diet with the addition of daily gazpacho intake.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse and Dietitian-Nutritionist (Assisted Reproduction)

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 29, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)