NCT04237779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

January 12, 2020

Last Update Submit

November 21, 2020

Conditions

Azoospermia, Nonobstructive

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (1)

  • IVF outcomes

    12 months

Study Arms (1)

PRP injection into at least one testis

EXPERIMENTAL

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

Interventions

PRP injection into at least one testisBIOLOGICAL

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.

PRP injection into at least one testis

Eligibility Criteria

Age25 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAzoospermia in at least 2 prior semen analysis. Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Azoospermia in at least 2 prior semen analysis.
  • Diagnosis of Non-Obstructive Azoospermia or Diagnosis of Cryptozoospermia

You may not qualify if:

  • Obstructive Azospermia
  • Anatomical abnormalities in the genital tract,
  • Cancer,
  • Hepatitis
  • Patients with systemic medical problems
  • Patients with chromosomal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Maslak Hospital IVF Unit

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 25722595BACKGROUND

  • 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.

    PMID: 29883240RESULT

MeSH Terms

Conditions

Azoospermia, Nonobstructive

Study Officials

  • Yigit Cakiroglu, Assoc.Prof.

    Acibadem University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 23, 2020

Study Start

January 27, 2020

Primary Completion

October 31, 2020

Study Completion

November 21, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)