Clinical trial NCT06100432: Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ Β-carotene) for Infertile Males
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Male Infertility
Keywords: Oligozoospermia
Lead sponsor: Duta Wacana Christian University
Sponsor class: OTHER
Collaborators: name: Dexa Medica Group
First posted: 2023-10-25
Enrollment: 90
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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, it will be total 90 subjects planned to be enrolled in the study.

There will be 3 groups of treatment:

Treatment 1: Eurycoma longifolia (DLBS5055) 200mg caplet Treatment 2: 2 caplets of Multivitamin (each caplet consists of Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU) Treatment 3: Eurycoma longifolia (DLBS5055) 200mg caplet and 2 caplets of Multivitamin (each caplet consists of Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)

Because this study will be double-blind randomized controlled trial, each subject still received 3 caplets (one caplet of DLBS5055 or its placebo and two caplets of multivitamin or their placebo), based on treatment group where the subject will be allocated. DLBS5055 caplet or its placebo will be administered once daily 30 minutes after lunch, whereas two multivitamin caplets will be administered once daily 30 minutes after breakfast.

Eligible subjects will be randomly allocated to receive either Treatment 1, Treatment 2 or Treatment 3 for 12 weeks. Subjects will be instructed to come to the clinic every 6-week interval throughout the 12-week study period (at the end of Week 6 and at the end of Week 12) for treatment evaluation. The semen analysis and reproductive hormonal evaluation will be performed at Baseline and at the End of therapy (Week 12). Additional testosterone level monitoring will be performed in the middle of study period (at the end of Week 6). Adverse events will be monitored at baseline and every follow-up visit including End of study (Week 12).

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.

Primary outcomes:
measure: Change from Baseline in Sperm Concentration measured in million per milliliter of ejaculates by LensHooke X1 PRO at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Progressive Sperm Motility measured in percentage (%) by LensHooke X1 PRO at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in Normal Sperm Morphology measured in percentage (%) by LensHooke X1 PRO at Week 12
timeFrame: Baseline and Week 12
measure: 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
timeFrame: Baseline and Week 12
measure: Change from Baseline in Serum Total Testosterone Level was determined using electro-chemiluminescence immunoassay (ECLIA) by COBAS 6000 core and measured in nanogram/deciliter
timeFrame: Baseline, Week 6 and Week 12
Secondary outcomes:
measure: Spontaneous Pregnancy Rate
timeFrame: Week 12
measure: Sexual Performance, measured by change from baseline of International Index of Erectile Function-5 (IIEF-5) Score
timeFrame: Baseline, Week 6 and Week 12
measure: Change from Baseline in SGOT (Serum Glutamic Oxaloacetic Transaminase) level was determined using IFCC method by Architect c4000 and measured in Unit per liter (U/L)
timeFrame: Baseline and Week 12
measure: Change from Baseline in SGPT (Serum Glutamic Pyruvic Transaminase) level was determined using IFCC method by Architect c4000 and measured in Unit per liter (U/L)
timeFrame: Baseline and Week 12
measure: Change from Baseline in Serum Blood Urea Nitrogen/BUN level was determined using urease method by Architect c4000 and measured in mg/dl
timeFrame: Baseline and Week 12
measure: Change from Baseline in Serum Creatinine level was determined using enzymatic method by Architect c4000 and measured in mg/dl.
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Laboratorium Klinik Pramita
Study officials:
affiliation: Duta Wacana Christian University
name: Seso S Suyono, MD
role: PRINCIPAL_INVESTIGATOR
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