The Efficacy of testicular Platelet Rich Plasma (PRP) for patients with history of Microdissection Testicular Sperm Extraction (mTESE) failure: Clinical Trial
Determining the effect of PRP on the process of spermatogenesis in azoospermic patients
Design
Clinical trial without control group, before and after, without blinding, randomized, phase 3 on 100 patients
Settings and conduct
This study will be conducted only on a group of 20 NOA patients referred to Royan Institute with negative mTESE history.
There is no control group and blinding will not be done. Also, in the first phase, the study will be conducted as a pilot, and after the data analysis, if the statistical analysis is significant - taking into account the primary goal of observing the treatment in these patients - the next phase of the study will be conducted.
After receiving the permission of the ethics committee in the research, the research samples will be selected based on the study entry criteria and after obtaining informed consent to participate in the research, they will be subjected to intratesticular PRP injection.
Participants/Inclusion and exclusion criteria
Men over 18 years with a history of non-obstructive azoospermia and at least one failed mTESE will be included in the study.
Intervention groups
After receiving the permission of the ethics committee in the research, the research samples after obtaining informed consent to participate in the research, they will be subjected to intratesticular PRP injection.
To prepare PRP, the PRP kit (Stem cell motivation kit, ROOYAGEN, Iran) will be used.
Main outcome variables
Comparing the effect of PRP on LH hormone levels after PRP injection
Comparing the effect of PRP on FSH and testosterone levels after PRP injection
Comparison of the effect of PRP on individual Semen Analysis after PRP injection
Comparison of the effect of PRP on the outcome of mTESE, after PRP injection
Determination of fertilization rate, clinical pregnancy (hCG positive), stable implantation (more than 8 weeks) if sperm is found
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221128056644N1
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2023-06-03, 1402/03/13
Update count:3
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Marjan Sabbaghian
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2730
Email address
Marjan.sabbaghian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of testicular Platelet Rich Plasma (PRP) for patients with history of Microdissection Testicular Sperm Extraction (mTESE) failure: Clinical Trial
Public title
The Efficacy of testicular PRP for patients with history of mTESE failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men over 18 years
Men with a history of non-obstructive azoospermia and at least one failed mTESE
Spouses without any disease related to female infertility
Exclusion criteria:
Obstructive azoospermia patients
Patients with systemic medical problems
Patients with chromosomal disorders
Spermatogenesis in non-obstructive azoospermia patients
Timepoint
Semen Analysis before PRP injection and 3 months after PRP injection. Also, if sperm is not observed, 6 months after PRP injection
Method of measurement
Semen Analysis and Microdissection Testicular Sperm Extraction
Secondary outcomes
1
Description
Determination of fertilization rate
Timepoint
After PRP injection
Method of measurement
Microscopic observations
Intervention groups
1
Description
Intervention group: Patients with non-obstructive azoospermia with a history of at least one mTESE failure. After receiving the permission of the ethics committee in the research, the research samples are selected based on the criteria for entering the study and after obtaining informed consent to participate in the research, they will be subjected to intratesticular injection of PRP. In order to prepare PRP, from the PRP kit ( Stem cell motivation kit, ROOYAGEN, Iran) will be used. The duration of PRP preparation will be less than 45 minutes. Prepared PRP is injected into the spermatic cord or into the interstitial space using a 5 ml syringe. In the third month after testicular PRP, gonadotropin stimulation in the patient's wife begins on days 2 to 4 of the menstrual cycle. Sperm extraction with the mTESE method will be performed at the same time as the egg retrieval day in order to use fresh sperm cells. In the first stage, 3 months after PRP injection into the testicles, sperm analysis will be checked in patients. The second stage will be 6 months after the injection. According to the obtained results, the sperm is injected into the cytoplasm of the egg by assisted reproductive techniques (ICSI) and fertilization takes place.