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Male InfertilityPhase 4NCT06100432

Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ β-carotene) for Infertile Males

A Phase 4 study testing DLBS5055 200mg and Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU) in people with Male Infertility, run by Duta Wacana Christian University at 1 site in Indonesia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Male Infertility
What is being tested?
DLBS5055 200mg and Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteIndonesia
Study dates
11 Nov 2023to 31 Oct 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Laboratorium Klinik Pramita

    Yogyakarta, Special Region of Yogyakarta

Other trials in Indonesia

About this study

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

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.

Read the 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).

Being tested
DLBS5055 200mg, Placebo DLBS5055, Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU), Placebo Multivitamin
Keywords
Oligozoospermia
Medical subject headings
Infertility, Male, Oligospermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DLBS5055 200mgDrug

    Also called Herbapoten

    1x1 caplet

  • Placebo DLBS5055Drug

    Also called Placebo Herbapoten

    1x1 caplet

  • Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)Drug

    Also called Oxyvit C+

    1x2 caplets

  • Placebo MultivitaminDrug

    Also called Placebo Oxyvit C+

    1x2 caplets

Study groups in NCT06100432
Study groupRoleWhat they receive
Treatment 1ExperimentalDLBS5055 \& Placebo Multivitamin
Receives: Drug: DLBS5055 200mg; Drug: Placebo Multivitamin
Treatment 2Active comparatorMultivitamin (Vitamin C 1000mg + Vitamin E 200IU + Beta Carotene 20000IU) \& Placebo DLBS5055
Receives: Drug: Placebo DLBS5055; Drug: Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)
Treatment 3ExperimentalDLBS5055 \& Multivitamin (Vitamin C 1000mg + Vitamin E 200IU + Beta Carotene 20000IU)
Receives: Drug: DLBS5055 200mg; Drug: Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Sperm Concentration measured in million per milliliter of ejaculates by LensHooke X1 PRO at Week 12

    LensHooke X1 PRO is a new semen quality analyzer. Its operation based on artificial intelligence optical microscopic (AIOM) technology and has been validated to have a high level of correlation and agreement with manual standard of semen analysis and Computer-Assisted Semen Analyzer (CASA).

    Sperm Concentration, as known as sperm density, is defined as the number of spermatozoa (sperm cell) per milliliter of ejaculates. According to the recent WHO laboratory manual for human semen analysis in 2021, sperm concentration more than 16 million per milliliter of ejaculates is considered normal.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  2. Change from Baseline in Progressive Sperm Motility measured in percentage (%) by LensHooke X1 PRO at Week 12

    LensHooke X1 PRO is a new semen quality analyzer. Its operation based on artificial intelligence optical microscopic (AIOM) technology and has been validated to have a high level of correlation and agreement with manual standard of semen analysis and Computer-Assisted Semen Analyzer (CASA).

    Progressive Sperm Motility refers to the proportion of spermatozoa (sperm cell) that swim progressively in a straight line or in a large circle from the whole sperm cells in ejaculates. It is measured in percentage (%). According to the recent WHO laboratory manual for human semen analysis in 2021, progressive sperm motility more than 30% is considered normal.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  3. Change from Baseline in Normal Sperm Morphology measured in percentage (%) by LensHooke X1 PRO at Week 12

    LensHooke X1 PRO is a new semen quality analyzer. Its operation based on artificial intelligence optical microscopic (AIOM) technology and has been validated to have a high level of correlation and agreement with manual standard of semen analysis and Computer-Assisted Semen Analyzer (CASA).

    Normal Sperm Morphology refers to the proportion of spermatozoa (sperm cell) with the normal form (according to Kruger Strict Morphology Criteria) from the whole sperm cells in ejaculates. It is measured in percentage (%). According to the recent WHO laboratory manual for human semen analysis in 2021, normal sperm morphology more than 4% is considered normal.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  4. 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

    Follicle-stimulating hormone (FSH) is a reproductive hormone secreted by the anterior pituitary in response to gonadotropin-releasing hormone (GnRH) from the hypothalamus. It indicates the ability of testis to produce sperm. According to our FSH reagent kit, normal serum FSH level in men is between 1,5-12,4 mIU/milliliter.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  5. Change from Baseline in Serum Total Testosterone Level was determined using electro-chemiluminescence immunoassay (ECLIA) by COBAS 6000 core and measured in nanogram/deciliter

    Testosterone is the primary reproductive hormone in male and responsible for producing male sex characteristic, spermatogenesis and fertility. According to our reagent kit, normal serum total testosterone level in men is between 249-836 nanogram/deciliter (ng/dL). Serum total testosterone level will be measured three times (baseline, week 6 and week 12).

    Change 1= (Week 6 Value - Baseline Value) Change 2= (Week 12 Value - Baseline Value)

    Measured: Baseline, Week 6 and Week 12

Secondary outcomes (6)

  1. Spontaneous Pregnancy Rate

    Spontaneous or Natural Pregnancy Rate among participants or subjects in each group Spontaneous Pregnancy Rate = number of participants whose partners conceive / total number of participants in the group

    Measured: Week 12

  2. Sexual Performance, measured by change from baseline of International Index of Erectile Function-5 (IIEF-5) Score

    International Index of Erectile Function-5 (IIEF-5) is a widely used diagnostic tool for diagnosing erectile dysfunction (ED). It is a validated self-administered questionnaire with possible score range from 5 to 25, and ED will be classified into five categories based on the scores: severe ED (score 5-7), moderate ED (score 8-11), mild to moderate ED (score 12-16), mild ED (score 17-21) and no ED (score 22-25).

    Change 1= (Week 6 Value - Baseline Value) Change 2= (Week 12 Value - Baseline Value)

    Measured: Baseline, Week 6 and Week 12

  3. 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)

    SGOT (Serum Glutamic Oxaloacetic Transaminase) or Aspartate aminotransferase (AST) is one of the important biomarkers to evaluate liver functions. AST is an enzyme found in muscle, kidney and highest concentration in liver and heart. Elevated levels of AST in human serum indicate hepatocellular damage. Normal AST in male adult is 0-37 U/L.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  4. 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)

    SGPT (Serum Glutamic Pyruvic Transaminase) or Alanine aminotransferase (ALT) is one of the important biomarkers to evaluate liver functions. ALT is an enzyme found mainly in kidney and greater concentration in liver cells. Any injury to liver cells will increase the serum ALT level. Normal ALT in male adult is 0-50 U/L.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  5. Change from Baseline in Serum Blood Urea Nitrogen/BUN level was determined using urease method by Architect c4000 and measured in mg/dl

    Blood Urea Nitrogen is a normal waste nitrogen product found in blood that comes from the breakdown of protein from foods. Increase levels of BUN indicates kidney failure. Normal BUN level is 6-20 mg/dl.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

  6. Change from Baseline in Serum Creatinine level was determined using enzymatic method by Architect c4000 and measured in mg/dl.

    Creatinine is the major metabolic product of protein. It is formed in muscles and excreted through kidney. Increase levels of creatinine indicates problems in kidney function due to several condition. Normal serum creatinine level is 0.67-1.17 mg/dl.

    Change = (Week 12 Value - Baseline Value)

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start11 Nov 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06100432
Sponsor's protocol ID
UST00223
Status last verified
Mar 2025
First submitted
6 Oct 2023
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharma A, Shrivastava D. Psychological Problems Related to Infertility. Cureus. 2022 Oct 15;14(10):e30320. doi: 10.7759/cureus.30320. eCollection 2022 Oct.

    PubMed 36407201

  • Tambi MI, Imran MK. Eurycoma longifolia Jack in managing idiopathic male infertility. Asian J Androl. 2010 May;12(3):376-80. doi: 10.1038/aja.2010.7. Epub 2010 Mar 29.

    PubMed 20348942

  • Agarwal A, Panner Selvam MK, Ambar RF. Validation of LensHooke(R) X1 PRO and Computer-Assisted Semen Analyzer Compared with Laboratory-Based Manual Semen Analysis. World J Mens Health. 2021 Jul;39(3):496-505. doi: 10.5534/wjmh.200185. Epub 2021 Feb 5.

    PubMed 33663026

  • Tang Z, Li D, Zhang X, Yi L, Zhu X, Zeng X, Tang Y. Comparison of the simplified International Index of Erectile Function (IIEF-5) in patients of erectile dysfunction with different pathophysiologies. BMC Urol. 2014 Jul 5;14:52. doi: 10.1186/1471-2490-14-52.

    PubMed 24996819

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DLBS5055 200mg and Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU) in people with Male Infertility, run by Duta Wacana Christian University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Sperm Concentration measured in million per milliliter of ejaculates by LensHooke X1 PRO at Week 12 (time frame: Baseline and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06100432, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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