Actively Recruiting
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress in Men With Altered Semen Parameters: A Randomized Controlled Study
Led by Ginefiv · Updated on 2026-03-13
80
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
G
Ginefiv
Lead Sponsor
I
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether drinking a daily serving of gazpacho can improve semen quality in men with altered sperm parameters such as oligozoospermia, asthenozoospermia, or teratozoospermia. The study also aims to understand if this dietary change affects oxidative stress levels in semen and whether daily gazpacho intake is well tolerated as part of a Mediterranean diet. This is a randomized, open-label study conducted at a single center focusing on male infertility and related conditions. Participants will be randomly assigned to one of two groups: one group will follow a standardized Mediterranean diet for 12 weeks, and the other group will follow the same diet plus consume 330 mL of commercially available gazpacho daily with a main meal. The study will analyze nutrient content in the gazpacho and monitor adherence through diaries and phone calls. The intervention period lasts 12 weeks, after which semen samples will be collected and analyzed. During the study, participants will provide semen samples at the start and after 12 weeks to assess changes in semen volume, sperm concentration, motility, and morphology following WHO 2021 guidelines. Oxidative stress in semen will also be measured using a specialized test. Participants will keep a diary to track adherence and will be followed for up to 18 months to record reproductive outcomes such as pregnancy and live birth rates. Safety, tolerability, and treatment adherence will be monitored throughout the study duration.
CONDITIONS
Brief Title
Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 to 45 years
- Altered semen parameters such as oligozoospermia, asthenozoospermia, and/or teratozoospermia
- No clinical indication for sperm DNA fragmentation testing or advanced sperm selection techniques
- Willingness and ability to follow a standardized Mediterranean diet
- Signed informed consent form
You will not qualify if you...
- Use of antioxidant supplements during the three months before the study
- Active smokers or those who stopped smoking within the last three months
- Diagnosis of azoospermia, leucocytospermia, or necrozoospermia
- Severe systemic diseases or chronic conditions affecting semen quality or study adherence
- Known allergy or intolerance to any ingredient in the gazpacho
- Any medical, psychological, or social condition that may affect participation or compliance
- Participation in another clinical study at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants follow a standardized Mediterranean diet for 12 weeks. Participants in the intervention group also consume 330 mL of gazpacho once daily with a main meal during this period. Adherence is monitored with compliance diaries and scheduled follow-up phone calls.
Regular follow-up phone calls and adherence monitoring
Duration - 18 months
Participants are followed for 18 months after the intervention to record reproductive outcomes such as pregnancy and live birth rates.
Periodic follow-up contacts over 18 months
Trial Site Locations
Total: 1 location
1
GINEFIV Madrid (IVIRMA Group)
Madrid, Madrid, Spain, 28010
Actively Recruiting
Research Team
P
Pablo Martí Pastor, RN, RDN
J
Julio Gijón de la Santa, Senior Clinical Embryologist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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