Comparison of the therapeutic effect of synbiotic with clomiphene in the treatment of idiopathic infertility in men
Design
A randomized, double blind clinical trial with a parallel group design of 30 patients in each group (totally 60 patients), and followed for 2 months. Randomization will be done with computer.
Settings and conduct
This study will be a double-blind clinical trial in 1398-99. The study population consisted of 20-50 year old male patients referred to infertility clinics in Bojnourd city who have been infertile for one year and their diagnosis is idiopathic. Patients in the study will be randomly assigned to either a probiotic group receiving one capsule daily or clomiphene (25 mg daily).
The patients will be randomly assigned to each group. Randomization will be done using a computer. For the purpose of random assignment correctly, the code of any intervention will be kept confidential by the clinic secretary, regardless of the patients' condition and in the envelopes. Then, the sealed envelopes will be delivered to treating physician to use for assigning patients to groups.
Participants/Inclusion and exclusion criteria
Including criteria:
Sperm concentration in semen <15000000 per cc;
Percentage of progressive motile spermatozoa < 32%;
Total motility <40%;
Total ejaculated spermatozoa<39*106;
Normal level of FSH, LH, Prolactin, and free testosterone in serum;
Excluding criteria:
Smoking or alcoholic consumption;
White blood cells in semen >106;
History of infertility therapy, chemotherapy and exposing to toxic agents on gonads;
Rule out of infertility with idiopathic oligoastenospermia.
Intervention groups
Intervention group: one capsule of Familact available in Iranian Pharmaceutical Market, orally
Control group: one capsule of clomiphene available in Iranian Pharmaceutical Market, orally
Main outcome variables
Semen Liquid Sperm Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190831044653N3
Registration date:2020-01-26, 1398/11/06
Registration timing:registered_while_recruiting
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Maryam Rameshrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7182
Email address
mrameshrad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of symbiotic therapy with clomiphene in male infertility with idiopathic oligoastenospermia: a randomized clinical trial
Public title
Comparing the effects of symbiotic therapy with clomiphene in male infertility with idiopathic oligoastenospermia: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
sperm concentration in semen <15000000 per cc
Percentage of progressive motile spermatozoa < 32%
Total motility <40%
Total ejaculated spermatozoa<39*106
Normal level of FSH, LH, Prolactin, and free testosterone in serum
Exclusion criteria:
Smoking or alcoholic consumption
White blood cells in semen >10 6
Chances of being treated with gonadotropins, anabolic steroids, cancer chemotherapy, NSAIDs
Have been treated with infertility medications since two months ago
Unwillingness to cooperate during treatment
A medical history of chemotherapy or radiotherapy for cancer management
A history of X ray radiation exposure since 8 months ago
Y chromosome microdeletion
Karyotype alterations
Testicular atrophy and lack of testicular descending
Other secondary causes of infertility
History of liver dysfunction and sensitivity to clomiphene
Medical history of infertility therapy since 2 months ago
Ejaculated volume <1.5 ml
Percentage of typical forms<4%
abnormal level of FSH, LH, prolactin and free testosterone in serum
Age
From 20 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used. At first, the block size is considered 4. Then, the possible ways to equally assign participants to a block will be written for 60 subjects. (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)-…- BAAB(n)). After that, numbers between 1-n will be chosen randomly from the table of random numbers which shows the ordinary of the blocks for participating in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Type of the interventions are kept in sealed envelopes and receive a code with no detail by the secretary. Doctors, patients and analyzer don't know the group of the patients. Two groups are nominated A or B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
shahria streat
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.NKUMS.REC.1398.094
Health conditions studied
1
Description of health condition studied
male infertility with idiopathic oligoastenospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm concentration in semen
Timepoint
end of study
Method of measurement
Sperm count in semen is calculated using sperm concentration. Sperm concentration refers to the number of sperm per unit volume of semen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one capsule of Familact available in Iranian Pharmaceutical Market, orally
Category
Treatment - Drugs
2
Description
Control group: one capsule contain of clomiphene available in Iranian Pharmaceutical Market, orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinics in Bojnourd city
Full name of responsible person
Abdollah razi
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Email
abdolahrazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
vice chanceller of research
Street address
Shahriar
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Email
abdolahrazi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Abdollah Razi
Position
Assictant
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shariar Streat
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 21 3229 7182
Email
abdolahrazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Rameshrad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shariar Streat
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 21 3229 7182
Email
mrameshrad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Rameshrad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahriar Street,
City
Bojnurd
Province
North Khorasan
Postal code
9417694786
Phone
+98 58 3229 7182
Fax
+98 58 3229 7182
Email
rameshrm2@mums.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