Evaluation of Safety and Efficacy of Intra-Testicular Injection of Allogenic Human Menstrual Blood Stem Cells Secretome in Non-Obstructive Azoospermia Patients
Evaluation of Saftey and Efficacy of Intra-Testicular Injection of Allogeneic Human Menstrual Blood Stem Cells Secretome in Non-Obstructive Azespermia Patients
Background: cell products
Location: Avicenna Infertility Center
Method: Administration of allogeneic secretome derived from menstrual blood, bilaterally, intratesticularly, 3 times, every month
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 25-45 years, non-obstructive azoospermia, and all items were explained on the previous page.
Exclusion criteria: under 25 years and over 40 years old, obstructive azoospermia, patients with non-obstructive azoospermia due to hypogonadotropic hypogonadism, receiving hormones and gonadotoxic drugs in the last 6 months and all items were explained in the previous page
Intervention groups
Evaluation of the safety and effectiveness of intratesticular injection of the secretome in ten patients with non-obstructive azoospermia who did not respond to conventional treatments. This intervention is defined as before and after treatment, and since there is no standard treatment for these patients, the control group has not been defined for this study.
Main outcome variables
Treatment of non-obstructive azoospermia using a product derived from stem cell
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221026056311N1
Registration date:2023-02-01, 1401/11/12
Registration timing:prospective
Last update:2023-02-01, 1401/11/12
Update count:0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Hannaneh Golshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
h.golshahi@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Safety and Efficacy of Intra-Testicular Injection of Allogenic Human Menstrual Blood Stem Cells Secretome in Non-Obstructive Azoospermia Patients
Public title
Evaluation of Safety and Efficacy of Secretome in Non-Obstructive Azoospermia Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-45 years old
BMI less than 35
Idiopathic non-obstructive azoospermia (maturation arrest)
Consent to TESE
Negative sperm test (2 test within 4 weeks)
FSH level more than 7.6 IU/L
Testes longitudinal axis less than 4.5 cm
At least 1 year since diagnosis
Testes volume less than 12 cc
Non-atrophic testes (confirm by ultrasound)
Normal karyotype
No intake of drug and hormonal medicine at least in the last 6 months
Negative sperm analysis
Exclusion criteria:
Patients older than 25 years old and under 45 years old
History of heart/brain stroke in the past year
Anemia or any other hematological disorders
History of pelvic trauma
Obstructive azoospermia
Patients with hypogonadotropic hypogonadism (HH) non-obstructive azoospermia (LH lower than 2IU/mL and FSH lower than 1 lU/mL)
Hormonal drugs and/or gonadotoxic drugs intake in the last 6 months
Infectious disease of genital system
History of testes surgery, biopsy of the testes and anatomical abnormality of genital system
History of alcohol and drug abuse
Tyroeid dysfunction
Immunu system diseases
History of cancer, chemotherapy or radiotherapy
Infected with Hepatitis B,C and HIV
Diabetic
Hepatic abnormality
Cryptozoospermia
Varicocele
Hyperprolactinemia
Chromosal disorder
Systemic disorders
Infertility factors in the sexual partner
Sexual partner over 40 years old
Age
From 25 years old to 45 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Avicenna Research Institute
Street address
Evin st. Shahid Beheshti University, Avicenna Research Institute, Tehran
City
Tehran
Province
Tehran
Postal code
1983969412
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1401.013
Health conditions studied
1
Description of health condition studied
Non-obstructive azoospermia
ICD-10 code
N46.0
ICD-10 code description
Azoospermia
Primary outcomes
1
Description
Acute side effects
Timepoint
24 hours, 72 hours, 1 week after each administration
Method of measurement
Clinical observation any signs of pain, allergy reaction, hemorrhage
2
Description
Spermatogenesis induction
Timepoint
3, 6 month and 1 year after the last adminstartion
Method of measurement
Sperm analysis, hematology, biochemistry, serum testosterone level, total serum follicle stimulating hormone (FSH), serum luteinizing hormone (LH) level, sexual function, measurement of the longitudinal axis of the testes
Secondary outcomes
1
Description
Spontaneous pregnancy
Timepoint
6 month and 1 year after the last injection
Method of measurement
Clinical observation
2
Description
Clinical pregnancy
Timepoint
6 months and 1 year after the last injection
Method of measurement
Clinical approach for pregnancy- clinical examination
Intervention groups
1
Description
Intervention group: Intra-testicular injection of human menstrual blood stem cells secretome. Under local anesthesia with 2% lidocaine (7mg/kg), the scrotum will be cleaned with normal saline solution and with the help of an ultrasonically guide. Under sterile conditions, secretome will be injected into the interstitial space of seminiferous tubules by a urologist surgeon. This intervention will be repeated every month for 3 times.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Avicenna Fertility Center
Full name of responsible person
Dr. Hannaneh Golshahi
Street address
Yakhchal st. Shariati st
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 23519
Email
h.golshahi@avicenna.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
dr. mohammad reza sadeghi
Street address
avicenna research center, shahid beheshti university, evin st, tehra, iran
City
tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 2243 2020
Email
sadeghi@avicenna.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Dr.Naser Amir Jannati
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Yakhchal st. Shariati st
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 23519
Email
namirjannati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr.Hannaneh Golshahi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin st
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
h.golshahi@avicenna.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr.Hannaneh Goshahi
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin st
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 2243 2020
Fax
+98 21 2243 2021
Email
h.golshahi@avicenna.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
No - There is not 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