Condition category
Urological and Genital Diseases
Date applied
10/10/2020
Date assigned
16/10/2020
Last edited
15/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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?
Mr Mahmoud Elnahas Hussein
elnahasinventor@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Mr Mahmoud Elnahas Hussien

ORCID ID

http://orcid.org/0000-0001-9854-9058

Contact details

Egypt Innovate for Development and Training Foundation
3 El-Molla Street
El-Zahraa
11782
Sohag
82524
Egypt
+20 (0)1146047576
Micheal.nashed@miuegypt.edu.eg

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Hussein280218

Study information

Scientific title

A dietary supplement for semen parameters quality improvement in low sperm count and azoospermia patients

Acronym

Study hypothesis

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

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

Study design

Single-center interventional before and after study

Primary study design

Interventional

Secondary study design

Before and after study design

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

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

Phase

Drug names

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 trial start date

20/05/2018

Overall trial end date

15/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

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

Participant 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

Recruitment start date

10/07/2018

Recruitment end date

01/11/2019

Locations

Countries of recruitment

Egypt

Trial participating centre

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

Sponsor information

Organisation

Egypt Innovate for Development and Training Foundation

Sponsor details

3 El-Molla Street
El-Zahraa
Cairo
11782
Egypt
+20 (0)1011011835
egyptedif@gmail.com

Sponsor type

Charity

Website

http://edif.com/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Egypt Innovate for Development and Training Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. Additional documents will be available at a later time.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/01/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/10/2020: Trial's existence confirmed by the clinical ethical committee of Egypt Innovate for Development and Training Foundation.