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The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia

Sponsor
Acibadem University (Other)
Overall Status
Completed
CT.gov ID
NCT04237779
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
9.8
Actual Duration (Months)
20.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PRP injection into at least one testis
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Intratesticular PRP Injection
Actual Study Start Date :
Jan 27, 2020
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Nov 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRP injection into at least one testis

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.

Biological: PRP injection into at least one testis
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.

Outcome Measures

Primary Outcome Measures

  1. sperm formation [6 months]

    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

  1. IVF outcomes [12 months]

    Number of participants with testicular PRP after TESE as assessed by number of clinical pregnancies, change in the clinical pregnancy rates with IVF treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acıbadem Maslak Hospital IVF Unit Istanbul Turkey

Sponsors and Collaborators

  • Acibadem University

Investigators

  • Study Director: Yigit Cakiroglu, Assoc.Prof., Acibadem University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bulent Tiras, Prof., Acibadem University
ClinicalTrials.gov Identifier:
NCT04237779
Other Study ID Numbers:
  • ATADEK 2019-4/23
First Posted:
Jan 23, 2020
Last Update Posted:
Nov 24, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Azoospermia

Study Results

No Results Posted as of Nov 24, 2020