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

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duta Wacana Christian University
• Collaborator: Dexa Medica Group
• Treatments: Beta Carotene; Carotenoids; Vitamin E; Vitamins

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.