Asthenozoospermia, Male Infertility, Oligozoospermia, Oxidative Stress, Subfertility, Teratozoospermia
Conditions
Keywords
Mediterranean diet, Gazpacho, sperm quality, Male infertility, Altered semen parameters, oxidative stress, OxiSperm II, Randomized trial
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
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.
Interventions
OTHERStandardized Mediterranean Diet
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.
DIETARY_SUPPLEMENTGazpacho
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.
Sponsors
Ginefiv
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sperm Concentration (million/mL) | 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 Ejaculate Volume (mL) | 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 Total Sperm Motility (%) | 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 (%) | 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 (%) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Seminal Oxidative Stress Signal (Color Units, CU) | Baseline to 12 weeks | 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. |
| Adherence to Gazpacho Intake (%) | Baseline to12 weeks | 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. |
| Incidence of Treatment-Emergent Adverse Events | Baseline to 12 weeks | 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. |
| Biochemical Pregnancy Rate | Up to 18 months post-intervention | 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. |
| Clinical Pregnancy Rate | Up to 18 months post-intervention | 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. |
| Miscarriage Rate | Up to 18 months post-intervention | Proportion of clinically confirmed pregnancies that result in pregnancy loss, calculated as the number of miscarriages divided by the total number of clinical pregnancies. |
| Live Birth Rate | Up to 18 months post-intervention | Proportion of pregnancies resulting in a live-born infant, calculated as the number of live births divided by the total number of clinical pregnancies. |
Countries
Spain
Contacts
CONTACTPablo Martí Pastor, RN, RDN
CONTACTJulio Gijón de la Santa, Senior Clinical Embryologist
PRINCIPAL_INVESTIGATORPablo Martí Pastor, RD, RND
Ginefiv Madrid (IVIRMA Group)
Outcome results
None listed