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

NCT06258759 | Recruiting DMC

• 1 other identifier: 151/2566
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Autologous Platelet-rich Plasma Supplement; Sperm Cryopreservation; Post-cryopreserved Sperm Quality; Semen Analysis

Keywords

Sperm; Platelet rich plasma; Vitrification; Cryopreservation; Semen analysis

Outcome Measures

Primary Outcomes (1)

• Sperm vitality

  Sperm vitality (percentage) after thawing

  14 days after cryopreservation

Secondary Outcomes (3)

• Sperm motility

  14 days after cryopreservation

• Sperm morphology

  14 days after cryopreservation

• DNA fragmentation

  14 days after cryopreservation

Study Arms (2)

experimental: semen

EXPERIMENTAL

a semen of normal semen analysis

Biological: autologous platelet-rich plasma supplement

placebo: semen

EXPERIMENTAL

a semen of normal semen analysis

Biological: no autologous platelet-rich plasma supplement

Interventions

autologous platelet-rich plasma supplement BIOLOGICAL

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: semen

no autologous platelet-rich plasma supplement BIOLOGICAL

the semen mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days

placebo: semen

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

RECRUITING

Central Study Contacts

Choermin Thitipatlertdech, M.D.

CONTACT

+6692-2659265; choermin@hotmail.com

Nisanart Booning, M.D.

CONTACT

+6684-1653945; tobee_b@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 14, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TH (1)