Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 5:15 AM
Study NCT ID:
NCT06258759
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation on Post-cryopreserved Sperm Quality
Sponsor:
Department of Medical Services Ministry of Public Health of Thailand
Organization:
Study Overview
Official Title:
The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sperm cryopreservation is an essential procedure for male fertility in certain situations, like cancer, vasectomy or other obstructive surgeries, autoimmunity diseases, immunosuppressive therapeutic strategies, or when the male partner is incapable of providing sufficient spermatozoa on the day of egg retrieval. Semen cryopreservation is mainly associated with decreased viability, motility, and DNA damage of spermatozoa due to the osmotic and mechanical stresses attributed to the freezing-thaw- ing process. Sperm cryodamage mainly originates from osmotic changes, cold shock, intracellular ice crystal formation, and oxidative stress. Based on this, some protective strategies have been proposed and developed, even the addition of cryoprotectants. Recently, Platelet-rich plasma (PRP) is becoming very popular in medicine. The therapeutic effect of platelets is related to alpha granule contents. A study showed that PRP modulates ROS toxicity through a different mechanism. VEGF detoxify oxidative damage via activation of the nuclear factor (erythroid- derived 2)-like2 (Nrf2) pathway. Oxidative stress modulation and apoptosis inhibition both have an essential role during the cryopreservation process. In this case, it raises the question of whether PRP can improve the sperm quality against freeze-thawing-induced damage. Therefore, the present study aimed to examine different concentrations of PRP on frozen-thawed sperm parameters of vitality, morphology, motility and DNA fragmentation
Detailed Description:
* Each participant will be collected a semen and PRP.
* Each semen will be separated into two specimens as the additional autologous platelet-rich plasma supplement group and control group (no adding autologous platelet-rich plasma). Both groups will undergo cryopreservation by Sperm vitrification for 14 days.
* The additional autologous platelet-rich plasma supplement group: the semen will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
* The control group (no adding autologous platelet-rich plasma): the semen will be mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
* After 14 days, the vitrified semen was transferred to a water bath of 37 °C for thawing. And analyzed Semen analysis via Computer Assisted Sperm Analysis: CASA and analyzed DNA fragmentation
* Each semen will be separated into two specimens as the additional autologous platelet-rich plasma supplement group and control group (no adding autologous platelet-rich plasma). Both groups will undergo cryopreservation by Sperm vitrification for 14 days.
* The additional autologous platelet-rich plasma supplement group: the semen will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
* The control group (no adding autologous platelet-rich plasma): the semen will be mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
* After 14 days, the vitrified semen was transferred to a water bath of 37 °C for thawing. And analyzed Semen analysis via Computer Assisted Sperm Analysis: CASA and analyzed DNA fragmentation
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: