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Completed

NCT Number: NCT06560216

Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

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?

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn Hospital, Bangkok, Thailand

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About this study

All normal semen samples from participants who give written informed consent and meet the eligibility requirements will be included in the study. Prepared semen samples were divided into 3 groups.

  • Pre-freezing sperm suspension
  • Frozen-thawed control without apigenin supplementation in freezing medium
  • Frozen-thawed sperm suspension with apigenin 0.2 mM supplementation in freezing medium Baseline sperm motility will be measured in pre-freezing sperm suspension. The last 2 groups will be stored in liquid nitrogen for at least one week. After thawing, the sperm suspensions will be evaluated for motility, viability, total antioxidant capacity, and oxidative stress markers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Apigenin

Dietary Supplement

0.2 mM in freezing medium

Primary outcomes

  1. Percentage of sperm motility

    Time frame: At least 1 week of freezing

    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.

Secondary outcomes

  1. Percentage of sperm viability comparison between intervention and control group

    Time frame: At least 1 week of freezing

    Viability test will be assessed by eosin-nigrosin staining technique

Other outcomes

  1. Total antioxidant capacity comparison between intervention and control group

    Time frame: At least 1 week of freezing

    Total antioxidant capacity will be assessed by ABTS assay

  2. Oxidative stress markers comparison between intervention and control group

    Time frame: At least 1 week of freezing

    Oxidative stress markers will be measured. e.g. reactive oxygen species

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Effects of Supplementation of Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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