Manfort: testing a dietary supplement for improving semen quality in patients with low or no sperm count
| ISRCTN | ISRCTN15796121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15796121 |
| Secondary identifying numbers | Hussein280218 |
- Submission date
- 10/10/2020
- Registration date
- 16/10/2020
- Last edited
- 10/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Recently dietary supplements composed from natural products extracted from medicinal herbs have been used for the improvement of sperm quality. This traditional method of treatment is safe, effective and low cost compared with drug treatment. This study will investigate the effectiveness of the Manfort supplement composed of natural extracts on patients with low sperm count or azoospermia (no sperm count).
Who can participate?
Adult male patients suffering from low sperm count or azoospermia.
What does the study involve?
The sperm quality of the patients will be compared before and after treatment with Manfort.
What are the possible benefits and risks of participating?
Semen quality may be improved. The Manfort supplement has not shown any side effects.
Where is the study run from?
Jannat Hospital (Egypt)
When is the study starting and how long is it expected to run for?
May 2018 to December 2020
Who is funding the study?
Egypt Innovate for Development and Training Foundation (Egypt)
Who is the main contact?
1. Mr Mahmoud Elnahas Hussein, elnahasinventor@gmail.com
2. Mr Ahmed Mahmoud Elnahas Hussein, mashaheeeer2002@gmail.com
Contact information
Public
Department of Chemistry, Faculty of Science, Sohag University
Naser City, The University Street
Sohag
82534
Egypt
| Phone | +20 (0)1146047576 |
|---|---|
| ahmedabudief@sohag.science.edu.eg |
Scientific
Egypt Innovate for Development and Training Foundation
Cairo
11782
Egypt
| Phone | +20 (0)155 4067883 |
|---|---|
| mashaheeeer2002@gmail.com |
Study information
| Study design | Single-center interventional before and after study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Before and after study design |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | A dietary supplement for semen parameters quality improvement in low sperm count and azoospermia patients |
| Study objectives | Multi-active antioxidants and anti-inflammatory ingredients found in a prepared dietary supplement called "Manfort" can improve the semen quality of azoospermia patients. The polyphenols and flavonoids are the main ingredients in Manfort supplement. These active antioxidants significantly improve semen volume, sperm concentration and sperm motility after treatment compared with before treatment. |
| Ethics approval(s) | Approved 05/10/2020, the clinical ethical committee of Egypt Innovate for Development and Training Foundation (3 El-Molla street, El-Zahraa, 11782, Cairo, Egypt; +20 (0)1011011835; egyptedif@gmail.com), ref: Hus/51020 |
| Health condition(s) or problem(s) studied | Semen quality improvement of patients with azoospermia and low sperm count |
| Intervention | A mixture of multi-active natural products, antioxidants, anti-inflammatory ingredients, and high-quality honey, called the 'Manfort supplement' will be used in this study. Male patients will be selected at random from the Jannat Hospital infertility clinic using sub-sequentially numbered dark closed envelopes by an independent third party. After informed consent, patients are divided into two groups. The first group contains patients with low sperm total count (˂17 million) and the second group contains with azoospermia (no sperm). Two semen specimens will be collected by masturbation after 4 days of last sexual abstinence. The specimens will be processed for analysis within 1 h after ejaculation in the andrology laboratory of the hospital to keep the quality of the semen specimen according to World Health Organization sample collection criteria. Semen examinations will be applied to analyze semen parameters such as volume, sperm concentration/ml of semen, total sperm count/ejaculate, sperm motility and white blood cells count in the semen. Sperm motility percentage will be evaluated according to the World Health Organization standard criteria. The data of these two groups (without treatment) will be considered as control data. After 15 days from the first semen sample collection and over 4 months, both low sperm count and azoospermia patients will be given 5 g Manfort dietary supplement three times daily after each meal at home. During all periods of the treatment, all patients will be followed up using phone contact or emails. After 4 months of treatment time, another two semen specimens will be collected from the patients. The data of these two groups (after treatment with Manfort) will be considered as data of the treated groups. Supplement dose: Manfort supplement (orally 5 g/three times/day for 4 months) |
| Intervention type | Supplement |
| Primary outcome measure | Measured at baseline (pre-treatment) and 4 months (post-treatment) from two semen specimens collected by masturbation: 1. Semen volume (by weight [g]) 2. Sperm concentration (hemacytometer) 3. Sperm motility (phase-contrast microscope) 4. Semen WBCs (high power field (HPF) using the hemacytometer slide and light microscope) |
| Secondary outcome measures | 1. Liver function measured using spectrophotometric assay of alanine transaminase (ALT) and aspartate aminotransferase (AST) |
| Overall study start date | 20/05/2018 |
| Completion date | 15/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 15 male patients with low sperm total count (˂ 17 million) and 18 patients (n = 18) with azoospermia (no sperm) |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Aged 36 to 46 years 2. Married 3. Low sperm total count: sperm concentration ˂17 million after two semen analysis tests 4. Azoospermia patients show spermatogonia cells in each semen analysis 5. Body weight ranging from 65 to 95 kg 6. All patients living in a geographic area where follow-up can be accomplished |
| Key exclusion criteria | 1. Patients suffering from other diseases such as varicocele were exempted from this study 2. Patients characterized with Sertoli cell only syndrome or absence of spermatogonia 3. Patients who take medications are exempted from this study to prevent semen analysis disturbance 4. Signs of infection or fever |
| Date of first enrolment | 10/07/2018 |
| Date of final enrolment | 01/11/2019 |
Locations
Countries of recruitment
- Egypt
Study participating centre
100 Takseem Elshorouk Street
Sohag
82524
Egypt
Sponsor information
Charity
3 El-Molla Street
El-Zahraa
Cairo
11782
Egypt
| Phone | +20 (0)1011011835 |
|---|---|
| egyptedif@gmail.com | |
| Website | http://edif.com/ |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Additional documents will be available at a later time. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/12/2019 | 16/02/2021 | Yes | No |
Editorial Notes
10/09/2021: Contact details updated.
03/08/2021: Contact details updated.
02/08/2021: Contact details updated.
16/02/2021: The following changes were made to the trial record:
1. The trial website was added.
2. Publication reference added.
12/10/2020: Trial's existence confirmed by the clinical ethical committee of Egypt Innovate for Development and Training Foundation.
