Investigating the effect of human menopausal gonadotropin and human chorionic gonadotropin treatment on testicular biopsy results in Klinefelter patients.
Investigating the effect of human menopausal gonadotropin and human chorionic gonadotropin treatment on testicular biopsy results in Klinefelter patients.
Design
This is a randomized clinical trial with a parallel design, which is nonblinded and with a control group. This study is randomized, phase 2-3 study will be conducted on at least 44 Klinefelter syndrome patients. A table of random numbers is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at the Bostan Clinic in Kermanshah, is a nonblinded one. The researcher and the participants have no role in the process of randomization and allocation of intervention and control groups. Medicines can only be identified through the serial number on the container.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Age between 18 and 65 years; Diagnosis of azoospermia based on semen analysis and urologist diagnosis; Married patients
Exclusion criteria: Any genetic disease other than Klinefelter that is associated with infertility; Presence of any concomitant disease that leads to infertility, such as varicocele; A history of infertility for any reason in the patient's wife; The patient's single testicle
Intervention groups
In the intervention group, HCG ampoules with a dose of 5000 units and HMG ampoules with a dose of 75 units are prescribed twice a week by intramuscular injection for 6 weeks.No medicine is prescribed in the control group.
Main outcome variables
Presence and absence of sperm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N207
Registration date:2023-08-20, 1402/05/29
Registration timing:prospective
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of human menopausal gonadotropin and human chorionic gonadotropin treatment on testicular biopsy results in Klinefelter patients.
Public title
Investigating the effect of human menopausal gonadotropin and human chorionic gonadotropin treatment on testicular biopsy results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age between 18 and 65 years
Diagnosis of azoospermia based on semen analysis and urologist diagnosis
Married patients
Exclusion criteria:
Any genetic disease other than Klinefelter that is associated with infertility
Presence of any concomitant disease that leads to infertility, such as varicocele
A history of infertility for any reason in the patient's wife
The patient's single testicle
Age
From 18 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method. To hide the random allocation, the method of closed envelopes with random sequence (SNOSE) will be used, a number of envelopes, preparation and each of the created random sequences will be recorded on a card and the cards will be placed in the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued, and it is placed inside the boxes in order. At the time of starting the registration of the participants, according to the order of entry of the eligible participants to the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.KUMS.MED.REC.1401.299
Health conditions studied
1
Description of health condition studied
Male Infertility
ICD-10 code
N46.1
ICD-10 code description
Oligospermia
Primary outcomes
1
Description
Presence and absence of sperm
Timepoint
The beginning of the study and the end of the study (6 weeks after the start of treatment)
Method of measurement
Sperm test
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, HCG ampoules with a dose of 5000 units and HMG ampoules with a dose of 75 units are prescribed twice a week by intramuscular injection for 6 weeks.