Determining and comparing the average number of motile sperm in the semen sample before and after HCG therapy in the control and intervention groups؛
Determining and comparing the average number of motile sperm in TESE samples after HCG therapy in control and intervention groups؛
Determining and comparing the average LH level in intervention and control groups before and after HCG therapy؛
Determining and comparing the average FSH level in intervention and control groups before and after HCG therapy؛
Determining and comparing the average prolactin level in intervention and control groups before and after HCG therapy؛
Determining and comparing the average testosterone level in intervention and control groups before and after HCG therapy؛
Design
Clinical trial with a control group, with parallel groups, double-blind, simple randomized, phase 2 on 64 patients.
Settings and conduct
Ali Bin Abi Taleb Zahedan Hospital; injection of hccg to azoospermic patients; Blinding: The patient and the researcher are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: male patients with infertility caused by non-obstructive azoospermia at least twice Semen Analysis
Exit criteria:
1- Male patients with obstructive azoospermia,
- Male patients who received exogenous testosterone,
3-- Male patients who receive chemotherapy or radiotherapy at the time of study,
4- Male patients with unilateral or bilateral unpalpable testicles and
5- Male patients with increased serum prolactin.
6- Male patients with confirmed chromosomal abnormalities
Intervention groups
In patients who meet the study entry criteria, HCG will be prescribed as 5000 IU subcutaneous injection twice a week for 10 to 14 weeks. The control group will not receive an injection.
Main outcome variables
Help to improve infertility
General information
Reason for update
Acronym
hcg
IRCT registration information
IRCT registration number:IRCT20240222061085N1
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Abdol-rahman Kalkali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 285 7422
Email address
abdikalkali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-19, 1402/12/29
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of HCG therapy on the amount of sperm extraction in men with non-obstructive azoospermia
Public title
The effect of HCG therapy on the amount of sperm extraction in men with non-obstructive azoospermia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients with infertility caused by non-obstructive azoospermia at least twice Semen Analysis
Exclusion criteria:
They received exogenous testosterone
receive chemotherapy or radiotherapy at the time of study
Unilateral or bilateral non-palpable testicles and
Increased serum prolactin.
Confirmed chromosomal abnormalities
Age
From 20 years old to 60 years old
Gender
Male
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
*Allocation concealment is done using 'coincidence sequence sealed opaque envelopes'. In this way, the random sequence is determined first, then the sequences are recorded on a card and the cards are placed in the envelopes in order. The outer surface of the envelopes is numbered and placed in the box in order. Participants will choose an envelope in order of entry and the intervention group will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
*Blinding: it is double-blind, the patient is not aware of the type of intervention performed, and on the other hand, the doctor evaluating the outcome of the study is also not aware of the type of treatment used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Persian Gulf Blvd., Dr. Hasabi Square, Zahedan Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.ZAUMS.REC.1402.419
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
The rate of sperm extraction in men with non-obstructive azoospermia
Timepoint
3 months after receiving hcg
Method of measurement
Sperm analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In patients who meet the study entry criteria, HCG will be prescribed as 5000 IU subcutaneous injection twice a week for 10 to 14 weeks. After the end of the HCG therapy period, sperm analysis will be taken from the patient's semen and the number of motile sperm as well as the serum level of LH, FSH, testosterone and prolactin will be checked and recorded. If in the Semen sample after HCG therapy, the patient still has azoospermia, he will be subjected to TESE for sperm extraction. In all stages of testing and sampling, patient information will remain confidential and ethical codes of research on human samples will be observed.
Category
Treatment - Drugs
2
Description
Control group: This group includes patients who are azoospermic and did not consent to receiving the HCG drug. This group will not receive drug treatment and will be followed periodically like the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali bin Abi Talib (AS) Zahedan Hospital
Full name of responsible person
AbdolRahman Kalkali
Street address
Persian Gulf Boulevard, Ali Bin Abi Taleb (AS) Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Abdikalkali@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Zahedan University of Medical Sciences
Street address
Fars Gulf Blvd., Dr. Hasabi Flat, Zahedan Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
abdikalkali@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
AbdolRahman Kalkali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Zibashar, Pirozi 4
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817911905
Phone
+98 915 285 7422
Email
Abdikalkali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdol-rahman Kalkali
Position
Urology resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Baharan complex, Payambar ahzam, Zibashar
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817911905
Phone
+98 915 285 7422
Fax
Email
abdikalkali@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdol-Rahman Kalkali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Zibashar, Pirozi 4
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817911905
Phone
+98 915 285 7422
Email
Abdikalkali@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data from infertile people receiving hcg
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
Scientific researchers
Under which criteria data/document could be used
The use of data in pregnancy research is not prohibited.
From where data/document is obtainable
Ali Bin Abi Talib (AS) Hospital - Research Center - Dr. Abdol-Rahman Kalkali
What processes are involved for a request to access data/document
After registering the research title in the field of fertility, it will be possible to access the data.