Male InfertilityG-OXSEMNCT07375238
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
A study testing Standardized Mediterranean Diet and Gazpacho in people with Male Infertility and Oxidative Stress, run by Ginefiv at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Male Infertility, Oxidative Stress, Subfertility
- What is being tested?
- Standardized Mediterranean Diet and Gazpacho
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
GINEFIV Madrid (IVIRMA Group)
Madrid, Madrid, 28010
Pablo Martí Pastor, RN, RDN, +34 669975090, pablo.marti@ginefiv.com
Julio Gijón de la Santa, Senior Clinical Embryologist, +34 636636799, julio.gijon@ginefiv.com
About this study
Official title: Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress in Men With Altered Semen Parameters: A Randomized Controlled Study
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Male Infertility, Oxidative Stress, Subfertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia
- Being tested
- Standardized Mediterranean Diet, Gazpacho
- Keywords
- Mediterranean diet, Gazpacho, sperm quality, Male infertility, Altered semen parameters, oxidative stress, OxiSperm II, Randomized trial
- Medical subject headings
- Infertility, Male, Infertility, Oligospermia, Asthenozoospermia, Teratozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standardized Mediterranean Diet; Dietary Supplement: Gazpacho |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 18 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start2 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ginefiv
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Responsible party
- Principal investigator, Pablo Martí, Ginefiv
- Investigators
- Pablo Martí Pastor, RD, RND, Principal investigator, Ginefiv Madrid (IVIRMA Group)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375238
- Sponsor's protocol ID
- 2506-GFMAD-082-PM
- Acronym
- G-OXSEM
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress in Men With Altered Semen Parameters: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07375238
- Acronym / sponsor ID
- G-OXSEM / 2506-GFMAD-082-PM
- Conditions
- Male Infertility, Oxidative Stress, Subfertility, Oligozoospermia, Asthenozoospermia, Teratozoospermia
- Keywords
- Mediterranean diet, Gazpacho, sperm quality, Male infertility, Altered semen parameters, oxidative stress, OxiSperm II, Randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- GinefivUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized Mediterranean Diet Alone (Control) | Active comparator | Other: Standardized Mediterranean DietParticipants 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. |
| Gazpacho + Standardized Mediterranean Diet (Intervention) | Experimental | Other: Standardized Mediterranean Diet, Dietary Supplement: GazpachoParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Mediterranean DietParticipants 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. | Other | Gazpacho + Standardized Mediterranean Diet (Intervention), Standardized Mediterranean Diet Alone (Control) |
| GazpachoParticipants 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. | Dietary supplement | Gazpacho + Standardized Mediterranean Diet (Intervention) |
Primary outcome
Change in Ejaculate Volume (mL)
Time frame: Baseline to 12 weeks
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.
Change in Sperm Concentration (million/mL)
Time frame: Baseline to 12 weeks
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.
Change in Total Sperm Motility (%)
Time frame: Baseline to 12 weeks
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.
Change in Progressive Sperm Motility (%)
Time frame: Baseline to 12 weeks
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.
Change in Normal Sperm Morphology (%)
Time frame: Baseline to 12 weeks
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.
7 secondary outcomes
Change in Seminal Oxidative Stress Signal (Color Units, CU)
Time frame: Baseline to 12 weeks
Adherence to Gazpacho Intake (%)
Time frame: Baseline to12 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 12 weeks
Biochemical Pregnancy Rate
Time frame: Up to 18 months post-intervention
Clinical Pregnancy Rate
Time frame: Up to 18 months post-intervention
Miscarriage Rate
Time frame: Up to 18 months post-intervention
Live Birth Rate
Time frame: Up to 18 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Martí Pastor, RD, RND principal investigator
Ginefiv Madrid (IVIRMA Group)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Mediterranean Diet and Gazpacho in people with Male Infertility and Oxidative Stress, run by Ginefiv at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Martí Pastor, RN, RDN (+34 669975090, pablo.marti@ginefiv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ejaculate Volume (mL) (time frame: Baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.