Status:
ACTIVE_NOT_RECRUITING
Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ Β-carotene) for Infertile Males
Lead Sponsor:
Duta Wacana Christian University
Collaborating Sponsors:
Dexa Medica Group
Conditions:
Male Infertility
Eligibility:
MALE
20-45 years
Phase:
PHASE4
Brief Summary
Infertility is defined as the inability of a couple to get pregnant after one year of regular and unprotected sexual intercourse. Although it is not a life-threatening condition, infertile couple ofte...
Detailed Description
Study population will be idiopathic infertile males who come to the study site. Those who meet inclusion and exclusion criteria will be randomized into three groups (30 subjects each group). Therefore...
Eligibility Criteria
Inclusion
- Male with idiopathic infertility
- Age 20-45 years
- Married and try to conceive.
- Being registered with the Indonesian Social Health Insurance Administration Body (BPJS).
- Has sperm concentration more than 5 million per mL.
- Has testosterone level between 350-600 ng/dl.
- Withdraw from any antioxidant treatment for at least 14 days before the enrollment of the study.
- Able to understand and provide Informed Consent
Exclusion
- Has a varicocele and other metabolic diseases such as diabetes mellitus.
- Has a history of surgery or injury in the genital region.
- Has a history of acute and chronic inflammatory diseases.
- Has a known allergy to any ingredients of the active or placebo material of the tested drugs (Eurycoma longifolia, Vitamin C, Vitamin E and Beta-carotene).
- Has a history of hormonal therapy in the last 6 months.
- Consumes any herbal or traditional medicine.
- Consumes any medicine contains steroid.
Key Trial Info
Start Date :
November 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06100432
Start Date
November 11 2023
End Date
October 31 2025
Last Update
March 27 2025
Active Locations (1)
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1
Laboratorium Klinik Pramita
Yogyakarta, Special Region of Yogyakarta, Indonesia