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

NCT06100432 | Active Not Recruiting Phase 4

• 1 other identifier: UST00223
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Infertility

Keywords

Oligozoospermia

Outcome Measures

Primary Outcomes (5)

• 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)

  Baseline and Week 12

• 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)

  Baseline and Week 12

• 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)

  Baseline and 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

  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)

  Baseline and Week 12

• 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)

  Baseline, Week 6 and Week 12

Secondary Outcomes (6)

• Spontaneous Pregnancy Rate

  Week 12

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

  Baseline, Week 6 and Week 12

• 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)

  Baseline and Week 12

• 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)

  Baseline and Week 12

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

  Baseline and Week 12

Study Arms (3)

Treatment 1

EXPERIMENTAL

DLBS5055 \& Placebo Multivitamin

Drug: DLBS5055 200mg; Drug: Placebo Multivitamin

Treatment 2

ACTIVE COMPARATOR

Multivitamin (Vitamin C 1000mg + Vitamin E 200IU + Beta Carotene 20000IU) \& Placebo DLBS5055

Drug: Placebo DLBS5055; Drug: Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)

Treatment 3

EXPERIMENTAL

DLBS5055 \& Multivitamin (Vitamin C 1000mg + Vitamin E 200IU + Beta Carotene 20000IU)

Drug: DLBS5055 200mg; Drug: Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)

Interventions

DLBS5055 200mg DRUG

1x1 caplet

Also known as: Herbapoten

Treatment 1; Treatment 3

Placebo DLBS5055 DRUG

1x1 caplet

Also known as: Placebo Herbapoten

Treatment 2

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

1x2 caplets

Also known as: Oxyvit C+

Treatment 2; Treatment 3

Placebo Multivitamin DRUG

1x2 caplets

Also known as: Placebo Oxyvit C+

Treatment 1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duta Wacana Christian University: lead
• Dexa Medica Group: collaborator

Study Sites (1)

Laboratorium Klinik Pramita

Yogyakarta, Special Region of Yogyakarta, Indonesia

Location

Related Publications (4)

• Zohman GL, Watts HG. Is a routine radiological consultation cost-effective for pediatric orthopedic radiographs? J Pediatr Orthop. 1998 Jul-Aug;18(4):549-51.

  PMID: 9661871 BACKGROUND

• Moskovko VM. [Circadian rhythm of blood clotting processes]. Voen Med Zh. 1986 May;(5):57. No abstract available. Russian.

  PMID: 3739276 BACKGROUND

• Zuckerman M. P-impulsive sensation seeking and its behavioral, psychophysiological and biochemical correlates. Neuropsychobiology. 1993;28(1-2):30-6. doi: 10.1159/000118996.

  PMID: 8255407 BACKGROUND

• Senciall IR, Rahal S, Sethumadhavan K. Solubilisation and fractional precipitation of a steroid alpha-ketol oxidase. J Steroid Biochem. 1985 Dec;23(6A):1083-5. doi: 10.1016/0022-4731(85)90072-x.

  PMID: 4094415 BACKGROUND

MeSH Terms

Conditions

Infertility, Male; Oligospermia

Interventions

Geritol; Ascorbic Acid; Vitamin E; beta Carotene

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Seso S Suyono, MD

  Duta Wacana Christian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 25, 2023
• Study Start: November 11, 2023
• Primary Completion: December 31, 2024
• Study Completion: October 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)