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

NCT ID: NCT04237779

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2020-11-21

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.

Conditions

Azoospermia, Nonobstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PRP injection into at least one testis

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Bulent Tiras

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yigit Cakiroglu, Assoc.Prof.

Role: STUDY_DIRECTOR

Acibadem University

Locations

Acıbadem Maslak Hospital IVF Unit

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 25722595 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29883240 (View on PubMed)

Other Identifiers

ATADEK 2019-4/23

Identifier Type: -

Identifier Source: org_study_id