Effect of hormonal therapy versus no treatment on testicular histopathology and fertility in patients with non-obstructive azoospermia: a before-after clinical trial
Objectives: To assess the effect of hormonal therapy versus no treatment on testicular histopathology and fertility in patients with non-obstructive azoospermia.
Design: a before-after clinical trial.
Setting and conduct: The eligible patients with non-obstructive azoospermia who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Male; non-obstructive azoospermia; normal sexual hormones.
Exclusion criteria: Severe testicular atrophy; varicocele; chromosomal abnormality; sertoli cell syndrome; hypogonadism.
Intervention group 1: Injection of HCG 5000 U intramuscularly once a week for 10 weeks.
Intervention group 2: Injection of FSH 75 U intramuscularly twice a week for 10 weeks.
Primary outcome: (a) sperm analysis 10 weeks after treatment through laboratory sampling; (b) histopathology of testis 10 weeks after treatment trough biopsy.
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612069014N137
Registration date:2016-12-18, 1395/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hormonal therapy versus no treatment on testicular histopathology and fertility in patients with non-obstructive azoospermia: a before-after clinical trial
Public title
Effect of hormonal therapy versus no treatment on testicular histopathology and fertility in patients with non-obstructive azoospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male; non-obstructive azoospermia; normal sexual hormones.
Exclusion criteria: Severe testicular atrophy; varicocele; chromosomal abnormality; sertoli cell syndrome; hypogonadism.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.130
Health conditions studied
1
Description of health condition studied
non-obstructive azoospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm analysis
Timepoint
10 weeks after treatment
Method of measurement
through laboratory sampling
2
Description
histopathology of testis
Timepoint
10 weeks after treatment
Method of measurement
trough biopsy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Injection of HCG 5000 U intramuscularly once a week for 10 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Injection of FSH 75 U intramuscularly twice a week for 10 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Farid Tahmoorsi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Farid Tahmoorsi
Position
Resident of Urology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
Farbod974@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohsen Alemi
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mohsenalemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)