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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

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

Study website

Contact information

Dr Ahmed M. Abu-Dief
Public

Department of Chemistry, Faculty of Science, Sohag University
Naser City, The University Street
Sohag
82534
Egypt

Phone +20 (0)1146047576
Email ahmedabudief@sohag.science.edu.eg
Mr Ahmed Mahmoud Elnahas Hussein
Scientific

Egypt Innovate for Development and Training Foundation
Cairo
11782
Egypt

Phone +20 (0)155 4067883
Email mashaheeeer2002@gmail.com

Study information

Study designSingle-center interventional before and after study
Primary study designInterventional
Secondary study designBefore and after study design
Study setting(s)Home
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleA dietary supplement for semen parameters quality improvement in low sperm count and azoospermia patients
Study hypothesisMulti-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
ConditionSemen quality improvement of patients with azoospermia and low sperm count
InterventionA 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 typeSupplement
Primary outcome measureMeasured 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 measures1. Liver function measured using spectrophotometric assay of alanine transaminase (ALT) and aspartate aminotransferase (AST)
Overall study start date20/05/2018
Overall study end date15/12/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants15 male patients with low sperm total count (˂ 17 million) and 18 patients (n = 18) with azoospermia (no sperm)
Total final enrolment33
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date10/07/2018
Recruitment end date01/11/2019

Locations

Countries of recruitment

  • Egypt

Study participating centre

Jannat Hospital
El-Safwa Tower
100 Takseem Elshorouk Street
Sohag
82524
Egypt

Sponsor information

Egypt Innovate for Development and Training Foundation
Charity

3 El-Molla Street
El-Zahraa
Cairo
11782
Egypt

Phone +20 (0)1011011835
Email egyptedif@gmail.com
Website http://edif.com/

Funders

Funder type

Other

Investigator initiated and funded

No information available

Egypt Innovate for Development and Training Foundation

No information available

Results and Publications

Intention to publish date01/01/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal. Additional documents will be available at a later time.
IPD sharing planThe 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.