Clinical TrialID 7779
Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ β-carotene) for Infertile Males
NCT06100432
Male Infertility
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7779
- Evidence Id
- 7779
- Core Evidence Id
- 7779
- Source Clinical Trial Id
- 7772
- Herb2 Clinical Trial Id
- HBCT007772
- Nct Id
- NCT06100432
- Title
- Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ β-carotene) for Infertile Males
- Status
- Recruiting
- Phase
- Phase 4
- Study Result
- No
- Study Condition
- Male Infertility
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: DLBS5055 200mg|DRUG: Placebo DLBS5055|DRUG: Multivitamin (Vitamin C 500mg + Vitamin E 100IU + Beta Carotene 10000IU)|DRUG: Placebo Multivitamin
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- Male
- Age
- Adult
- Enrollment
- 90
- Outcome Measure
- 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
- Sponsor Collaborator
- Duta Wacana Christian University|Dexa Medica Group
- Funded By
- OTHER
- Location
- Laboratorium Klinik Pramita, Yogyakarta, Indonesia
- Other Id
- UST00223
- Start Date
- 2023-11-11
- Primary Completion Date
- 2024-11-01
- Completion Date
- 2024-11-01
- First Posted
- 2023-10-25
- Results First Posted
- Last Update Posted
- 2023-12-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT06100432
- Title Cn
- Title En
- Effect of Eurycoma Longifolia (DLBS5055) and Multivitamins (Vitamin C+Vitamin E+ β-carotene) for Infertile Males
- Bilingual Status
- semi_complete