The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia
Primary Purpose
Azoospermia, Nonobstructive
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PRP injection into at least one testis
Sponsored by
About this trial
This is an interventional treatment trial for Azoospermia, Nonobstructive
Eligibility Criteria
Inclusion Criteria:
- Azoospermia in at least 2 prior semen analysis.
- Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia
Exclusion Criteria:
- Obstructive Azospermia
- Anatomical abnormalities in the genital tract,
- Cancer,
- Hepatitis
- Patients with systemic medical problems
- Patients with chromosomal disorders
Sites / Locations
- Acıbadem Maslak Hospital IVF Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP injection into at least one testis
Arm Description
Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under local anesthesia. Sperm analysis, testicular volumes (using orchiometer), serum FSH and testosterone measurements will be re-evaluated at 8 weeks post-procedure. On the third month after the procedure, presence of spermatozoa will be reassessed in microTESE material.
Outcomes
Primary Outcome Measures
sperm formation
Number of participants with testicular PRP treatment as assessed by testicular sperm extraction, change from azoospermia or cryptozoospermia to presence of sperm during TESE procedure
Secondary Outcome Measures
IVF outcomes
Number of participants with testicular PRP after TESE as assessed by number of clinical pregnancies, change in the clinical pregnancy rates with IVF treatment.
Full Information
NCT ID
NCT04237779
First Posted
January 12, 2020
Last Updated
November 21, 2020
Sponsor
Acibadem University
1. Study Identification
Unique Protocol Identification Number
NCT04237779
Brief Title
The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia
Official Title
The Effects of Intratesticular PRP Injection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
November 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be conducted in men with a diagnosis of non-obstructive azoospermia or cryptozoospermia after obtaining written informed consent. The diagnosis of azoospermia and cryptozoospermia will be based on two semen analyses performed at least 15 days apart, followed by a documented micro testicular sperm extraction (TESE). A detailed history will be obtained, physical examination and laboratory evaluation will be performed prior to treatment. In physical examination, testicular volumes will be evaluated using an orchiometer. Serum FSH and testosterone values will be determined. PRP will be prepared by centrifugation of approximately 20 ml autologous blood obtained by phlebotomy. PRP (3 ml) will be administered into the seminiferous tubule or interstitial space of each testis. Sperm analysis, testicular volume (using orchiometer), serum FSH and testosterone levels will be reevaluated at 8 weeks post-procedure. Micro TESE will performed on the third month after PRP procedure.
Detailed Description
Platelet-rich plasma (PRP) is a unique autologous agent derived from blood that is rich in growth factors, cytokines, and hormones; it has been reported to reduce oxidative stress and reactive oxygen species generation and upregulate the expression of various antioxidant enzymes. PRP is used in a variety of clinical applications in cell therapy. Based on World Health Organization guidelines, azoospermia is diagnosed when the absence of sperm is observed in two semen samples. Based on World Health Organization (WHO), cryptozoospermia is diagnosed when spermatozoa cannot be observed in a fresh semen sample; however, it is found after an extended centrifugation and microscopic search. All patients require a clinical work-up with physical examination, endocrine evaluation (follicle stimulating hormone (FSH), luteinizing hormone (LH) and testosterone) and genetic analysis. Scrotal and transrectal ultrasounds will be performed as indicated. Platelet-rich plasma (PRP), with its rich growth factor composition, has proven beneficial in regenerative therapy. The potential therapeutic role of PRP has not been studied in testis for non-obstructive azoospermia and cryptozoospermia. The investigators will investigate sperm parameters in non-obstructive azoospermic and crypotozoospermic patients treated with PRP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia, Nonobstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP injection into at least one testis
Arm Type
Experimental
Arm Description
Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under local anesthesia. Sperm analysis, testicular volumes (using orchiometer), serum FSH and testosterone measurements will be re-evaluated at 8 weeks post-procedure. On the third month after the procedure, presence of spermatozoa will be reassessed in microTESE material.
Intervention Type
Biological
Intervention Name(s)
PRP injection into at least one testis
Intervention Description
Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under local anesthesia. Sperm analysis, testicular volumes (using orchiometer), serum FSH and testosterone measurements will be re-evaluated at 8 weeks post-procedure. On the third month after the procedure, presence of spermatozoa will be reassessed in micro testicular sperm extraction (TESE) material.
Primary Outcome Measure Information:
Title
sperm formation
Description
Number of participants with testicular PRP treatment as assessed by testicular sperm extraction, change from azoospermia or cryptozoospermia to presence of sperm during TESE procedure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
IVF outcomes
Description
Number of participants with testicular PRP after TESE as assessed by number of clinical pregnancies, change in the clinical pregnancy rates with IVF treatment.
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Azoospermia in at least 2 prior semen analysis. Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Azoospermia in at least 2 prior semen analysis.
Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia
Exclusion Criteria:
Obstructive Azospermia
Anatomical abnormalities in the genital tract,
Cancer,
Hepatitis
Patients with systemic medical problems
Patients with chromosomal disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yigit Cakiroglu, Assoc.Prof.
Organizational Affiliation
Acibadem University
Official's Role
Study Director
Facility Information:
Facility Name
Acıbadem Maslak Hospital IVF Unit
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25722595
Citation
Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
Results Reference
background
PubMed Identifier
29883240
Citation
Dehghani F, Sotoude N, Bordbar H, Panjeshahin MR, Karbalay-Doust S. The use of platelet-rich plasma (PRP) to improve structural impairment of rat testis induced by busulfan. Platelets. 2019;30(4):513-520. doi: 10.1080/09537104.2018.1478400. Epub 2018 Jun 8.
Results Reference
result
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The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia
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