Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ β-carotene) on Sperm Parameters and Reproductive Hormones of Infertile Males in Yogyakarta, Indonesia
Trial ID: NCT06100432
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE4
Start date: 2023-11-11
Completion date: 2025-10-31
Sponsor: Duta Wacana Christian University
Collaborators: Dexa Medica Group
Conditions: Male Infertility
Interventions: DLBS5055 200mg; Placebo DLBS5055; Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU); Placebo Multivitamin
Locations: Laboratorium Klinik Pramita
Countries: Indonesia
Enrollment: 90
Age range: 20 Years - 45 Years
Sex: MALE

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 often suffer from mental health issues, including depression and low self-esteem that may impact their Quality of Life (QoL). Male factors contribute to a half of the underlying causes of infertility and semen analysis play a vital role in investigation of the fertility status of the male partners. By performing semen analysis, we could predict the chance of a couple to conceive.

Male infertility treatments include surgery, hormonal treatment and also assisted reproductive techniques, such as intra uterine insemination and in vitro fertilization that may lead to a financial burden for infertile couple. For facing this issue, traditional or herbal medicine and antioxidants are often be used as an alternative way by many infertile couples. One of the traditional medicines used in Indonesia and other Southeast-Asia Countries for infertility cases is Eurycoma longifolia or Pasak Bumi.

Based on previous studies in animals, Eurycoma longifolia could improve Testosterone and may improve sperm parameters, even though there are very few studies in human including in Indonesia. Antioxidants (multivitamins) are also routinely given to the infertile men as they could protect sperm damages from oxidative stress and may in advanced improve sperm quantity and quality. Our study aims to compare the effect of Eurycoma longifolia, Multivitamins and the combination on sperm parameters and also reproductive hormones of the infertile males.

Eligibility criteria:
Inclusion Criteria:

1. Male with idiopathic infertility
2. Age 20-45 years
3. Married and try to conceive.
4. Being registered with the Indonesian Social Health Insurance Administration Body (BPJS).
5. Has sperm concentration more than 5 million per mL.
6. Has testosterone level between 350-600 ng/dl.
7. Withdraw from any antioxidant treatment for at least 14 days before the enrollment of the study.
8. Able to understand and provide Informed Consent

Exclusion Criteria:

1. Has a varicocele and other metabolic diseases such as diabetes mellitus.
2. Has a history of surgery or injury in the genital region.
3. Has a history of acute and chronic inflammatory diseases.
4. 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).
5. Has a history of hormonal therapy in the last 6 months.
6. Consumes any herbal or traditional medicine.
7. Consumes any medicine contains steroid.

Outcomes:
Change from Baseline in Sperm Concentration measured in million per milliliter of ejaculates by LensHooke X1 PRO at Week 12; Change from Baseline in Progressive Sperm Motility measured in percentage (%) by LensHooke X1 PRO at Week 12; Change from Baseline in Normal Sperm Morphology measured in percentage (%) by LensHooke X1 PRO at Week 12; Change from Baseline in Serum Follicle Stimulating Hormone Level was determined using electro-chemiluminescence immunoassay (ECLIA) by COBAS 6000 core and measured in mIU/milliliter; Change from Baseline in Serum Total Testosterone Level was determined using electro-chemiluminescence immunoassay (ECLIA) by COBAS 6000 core and measured in nanogram/deciliter