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

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

Interventions

DRUG

DLBS5055 200mg

1x1 caplet

DRUG

Placebo DLBS5055

1x1 caplet

DRUG

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

1x2 caplets

DRUG

Placebo Multivitamin

1x2 caplets

Sponsors & Collaborators

• Dexa Medica Group

  collaborator INDUSTRY

• Duta Wacana Christian University

  lead OTHER

Principal Investigators

• Seso S Suyono, MD · Duta Wacana Christian University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-11

Primary Completion

2024-12-31

Completion

2025-10-31

Countries

• Indonesia

Study Locations