Efficacy and safety of Tribulus terrestris products for men with low sperm count

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of products derived from Tribulus terrestris in men diagnosed with oligospermia, a condition characterized by low sperm count. Participants will receive either the investigational product or a placebo, and the study aims to determine if the benefits of the treatment outweigh any associated risks. The study is designed to carefully monitor participant safety and health throughout the intervention period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. \- Male;
2. \- Ages 25 and 60;
3. \- Diagnosis of oligospermia;
4. \- With sexual partner;
5. \- Indication of drug treatment with steroid hormones, precursors or analogues.

Exclusion Criteria:

1. \- Severe oligospermia
2. \- Anatomical change
3. \- Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
4. \- BMI 35;
5. \- Participant who presents liver enzyme and creatinine values above the upper limit of normality;
6. \- History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone;
7. \- Hypersensitivity to any ingredient present in the formulation;
8. \- Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety;
9. \- Proven infertility of the partner;
10. \- History of genetic disorder;
11. \- History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk;
12. \- Active cancer at the discretion of the Investigator;
13. \- Participants with pregnant and breastfeeding partners;
14. \- Cycling and horse riding more than 3 hours per week;
15. \- Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism;
16. \- Smoking greater than half a pack per day or equivalent.

Where it's running

• Azidus Brasil Pesquisa Científica E Desenvolvimento Ltda
  Valinhos, São Paulo, Brazil Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This project will collect DNA from adults with NOA, oligospermia, or POI to try to find gene changes that may cause their infertility.

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• Treatment for severe male infertility using MediReg®

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• Hyperbaric oxygen therapy for men with low sperm count

  This study is testing if hyperbaric oxygen therapy can help men with low sperm count improve their fertility.

  Recruiting Assaf-Harofeh Medical Center · Tsrifin · NCT05842239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.