Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

NCT06560216 | Completed

• 1 other identifier: 062267
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to compare the effect of apigenin supplementation in freezing medium with no apigenin supplementation in freezing medium on post-thaw human sperm motility. It will also evaluate the sperm viability, total antioxidant capacity, and oxidative stress markers. The main questions it aims to answer are:

• Does apigenin supplementation in freezing medium improve the post-thaw sperm motility?
• Does apigenin supplementation in freezing medium improve the post-thaw sperm viability, total antioxidant capacity, and oxidative stress?

Conditions

Healthy

Keywords

Apigenin; Cryopreservation; Antioxidant; Human sperm; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Percentage of sperm motility

  Sperm motility (total motility, progressive motility, non-progressive motility, immotile spermatozoa) will be reported in percentage. Compare results among freezing medium with apigenin group, control group, and baseline pre-freeze sperm suspension.

  At least 1 week of freezing

Secondary Outcomes (1)

• Percentage of sperm viability comparison between intervention and control group

  At least 1 week of freezing

Other Outcomes (2)

• Total antioxidant capacity comparison between intervention and control group

  At least 1 week of freezing

• Oxidative stress markers comparison between intervention and control group

  At least 1 week of freezing

Study Arms (2)

Control

NO INTERVENTION

Frozen-thawed sperm suspension without apigenin supplementation in freezing medium

Apigenin

EXPERIMENTAL

Frozen-thawed sperm suspension with apigenin 0.2 mM supplementation in freezing medium

Dietary Supplement: Apigenin

Interventions

Apigenin DIETARY_SUPPLEMENT

0.2 mM in freezing medium

Apigenin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men aged 18-45 years who can receive semen analysis services at the Reproductive Biology Unit, Chulalongkorn Hospital, Thai Red Cross Society
• Normal semen analysis results according to the World Health Organization criteria (Volume ≥ 1.4 mL, Sperm concentration ≥ 16 million/mL, Total motility ≥ 42%, Progressive motility ≥ 30%)
• Giving consent

You may not qualify if:

• A history of accidents, radiation to the testes, or a history of male reproductive system surgery
• Undescended testis
• Varicocele
• A history of taking certain medications that affect sperm production, such as chemotherapy, hormones
• Currently having sexually transmitted disease

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (2)

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (56)

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  RESULT

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MeSH Terms

Interventions

Apigenin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Punyawee Utaipatanacheep

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Frozen-thawed control without apigenin supplementation in freezing medium 2. Frozen-thawed sperm suspension with apigenin supplementation in freezing medium

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: October 28, 2024
• Primary Completion: February 12, 2025
• Study Completion: March 3, 2025
• Last Updated: March 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)