The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation on Post-cryopreserved Sperm Quality

The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation

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

Study Overview

• Status: Recruiting
• Conditions: Autologous Platelet-rich Plasma Supplement; Sperm Cryopreservation; Post-cryopreserved Sperm Quality; Semen Analysis
• Intervention / Treatment: Biological: autologous platelet-rich plasma supplement; Biological: no autologous platelet-rich plasma supplement

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Choermin Thitipatlertdech, M.D.; Phone Number: +6692-2659265; Email: choermin@hotmail.com
• Study Contact Backup: Name: Nisanart Booning, M.D.; Phone Number: +6684-1653945; Email: tobee_b@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Rajavithi Hospital
    • Contact: Choermin Thitipatlertdech; Phone Number: +6692-2659265; Email: choermin@hotmail.com
    • Contact: Nisanart Booning; Phone Number: +6684-1653945; Email: tobee_b@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. A man who be a Rajavithi hospital clients or staff.
2. Aged 20-40 years old.
3. Has normal semen analysis.
4. Can communicate and understand Thai language very well.
5. Voluntarily participated in the research.
6. Sexual abstinence for 2-7 days.

Exclusion Criteria:

1. A man who ever diagnosed with infertile patient.
2. A wan who diagnosed with any hematological disease such as Coagulation disorders, Hypertension, Thrombocytopenia, Platelet dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental: semen; a semen of normal semen analysis	Biological: autologous platelet-rich plasma supplement; the semen of the additional autologous platelet-rich plasma supplement group will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days
Experimental: placebo: semen; a semen of normal semen analysis	Biological: no autologous platelet-rich plasma supplement; the semen mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm vitality	Sperm vitality (percentage) after thawing	14 days after cryopreservation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm motility	Sperm motility (percentage) after thawing	14 days after cryopreservation
Sperm morphology	Sperm morphology (percentage of normal form) after thawing	14 days after cryopreservation
DNA fragmentation	DNA fragmentation (percentage) after thawing	14 days after cryopreservation

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vitrification; Sperm; Cryopreservation; Platelet rich plasma; Semen analysis
• Other Study ID Numbers: 151/2566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No