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

NCT ID: NCT06258759

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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* 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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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experimental: semen

a semen of normal semen analysis

Group Type EXPERIMENTAL

autologous platelet-rich plasma supplement

Intervention Type 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

placebo: semen

a semen of normal semen analysis

Group Type EXPERIMENTAL

no autologous platelet-rich plasma supplement

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

no autologous platelet-rich plasma supplement

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajavithi hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Choermin Thitipatlertdech, M.D.

Role: CONTACT

+6692-2659265

Nisanart Booning, M.D.

Role: CONTACT

+6684-1653945

Facility Contacts

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Choermin Thitipatlertdech

Role: primary

+6692-2659265

Nisanart Booning

Role: backup

+6684-1653945

Other Identifiers

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151/2566

Identifier Type: -

Identifier Source: org_study_id

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