Protocol summary

Study aim
Evaluation of the therapeutic effect of synbiotics in the treatment of idiopathic oligoastenospermia in men
Design
Blind two-way clinical trial; patients were randomly assigned to two groups of 20 recipients of femoral lactate or placebo by blockchain and would receive their group medication once daily for 4 weeks. Therefore, on a basic basis, demographic and clinical information of registered patients, as well as a serum sample will be taken for the necessary analyzes.
Settings and conduct
Yazd Reproductive Research Institute
Participants/Inclusion and exclusion criteria
Admission requirements: Age 20 to 50 years, Sperm concentration below 15 million per cc, Percentage of progressive motile spermatozoa < 32%, Total ejaculated spermatozoa<39*106, Total motility <40%, Normal serum levels of free testosterone, Prolactin, Luteinizing hormone, Follicle-stimulating hormone, Conditions for not entering the study: Drug or alcohol abuse, Concentration of white blood cells in semen > 106 per cc, Possibility of being treated with gonadotropins, anabolic steroids, cancer chemotherapy, NSAIDs, infertility medications in the last two months, Previous history of chemotherapy or radiotherapy for cancer, Existence of palpable varicocele, X-ray history of the past eight months, Y chromosome microdeletion, Karyotype alterations, Testicular atrophy and testicular failure, Other secondary causes of infertility, A history of liver problems and a history of allergy to clomiphene, Percentage of typical forms<4%, Ejaculated volume <1.5 ml, Abnormal serum levels of free testosterone, Prolactin, Luteinizing hormone, Follicle-stimulating hormone
Intervention groups
Intervention group:They receive FamiLact capsules once a day for 4 weeks. Control group: They receive placebo once a day for 4 weeks.
Main outcome variables
Sperm concentration; sperm motility; sperm morphology; semen fluid volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190810044500N6
Registration date: 2020-09-05, 1399/06/15
Registration timing: prospective

Last update: 2020-09-05, 1399/06/15
Update count: 0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of symbiotic therapy in male infertility with idiopathic oligoastenospermia
Public title
Evaluating the effects of symbiotic therapy in male infertility with idiopathic oligoastenospermia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 50 years Sperm concentration below 15 million per cc Percentage of progressive motile spermatozoa < 32% Total ejaculated spermatozoa<39*106 Total motility <40% Normal serum levels of free testosterone, Prolactin, Luteinizing hormone, Follicle-stimulating hormone
Exclusion criteria:
Drug or alcohol abuse Concentration of white blood cells in semen > 106 per cc Possibility of being treated with gonadotropins, anabolic steroids, cancer chemotherapy, NSAIDs, infertility medications in the last two months Previous history of chemotherapy or radiotherapy for cancer Existence of palpable varicocele X-ray history of the past eight months Y chromosome microdeletion Karyotype alterations Testicular atrophy and testicular failure Other secondary causes of infertility A history of liver problems and a history of allergy to clomiphene Percentage of typical forms<4% Ejaculated volume <1.5 ml Abnormal serum levels of free testosterone, Prolactin, Luteinizing hormone, Follicle-stimulating hormone
Age
From 20 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of recipients of femoral lactate or placebo capsules using Random Allocation software using reciprocating blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
All stages will be covered by the patient, physician, and evaluator. The first presenter identifies the sequence of assignment of patients according to the order of entry of the patients to the study and places the drugs in a uniform envelope and identifies them with A or B codes. He then identifies the medications that are appropriate for each individual according to the above description and puts them in special envelopes and delivers them to patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of ethics of medical sciences, shahid sadoughi university of medical sciences
Street address
Professor Hesabi Blvd, Yazd Province
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2020-07-07, 1399/04/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.057

Health conditions studied

1

Description of health condition studied
Idiopathic oligoasthenospermia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sperm concentration in semen
Timepoint
Before the intervention and after the intervention
Method of measurement
Spermatogram test

2

Description
Sperm motility in semen
Timepoint
Before the intervention and after the intervention
Method of measurement
Spermatogram test

3

Description
Sperm morphology in Semen
Timepoint
Before the intervention and after the intervention
Method of measurement
Spermatogram test

4

Description
Semen fluid volume
Timepoint
Before the intervention and after the intervention
Method of measurement
Spermatogram test

5

Description
Semen fluid Power Hydrogen
Timepoint
Before the intervention and after the intervention
Method of measurement
Spermatogram test

6

Description
Serum concentration of free testosterone, prolactin, luteinizing hormone, follicle-stimulating hormone
Timepoint
Before the intervention and after the intervention
Method of measurement
Blood test

Secondary outcomes

1

Description
Age
Timepoint
Before the intervention and after the intervention
Method of measurement
Questionnaire

2

Description
Height
Timepoint
Before the intervention and after the intervention
Method of measurement
Questionnaire

3

Description
Weight
Timepoint
Before the intervention and after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group:They receive FamiLact capsules once a day for 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: They receive placebo once a day for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Research Institute
Full name of responsible person
Fatemeh Saghafi
Street address
Safaieh, Timsar Fallahi Street
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3824 7085
Email
ivf@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohamad Reza Mirjalili
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 1171
Fax
+98 35 3724 0371
Email
ravabet@SSU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd, Yazd Province, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd, Yazd Province, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Blvd, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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