Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Apigenin

• Registration Number: NCT06560216
• Lead Sponsor: Chulalongkorn University

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?

Detailed Description

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.

1. Pre-freezing sperm suspension

2. Frozen-thawed control without apigenin supplementation in freezing medium

3. 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.

Study Timeline

• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Study First Posted: 2024-08-19
• Status Verified: 2024-10
• Study Start: 2024-10-28
• Primary Completion: 2025-02-12
• Study Completion: 2025-03-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apigenin	Apigenin	Frozen-thawed sperm suspension with apigenin 0.2 mM supplementation in freezing medium

Primary Outcome Measures

Name	Time	Method
Percentage of sperm motility	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 Outcome Measures

Name	Time	Method
Percentage of sperm viability comparison between intervention and control group	At least 1 week of freezing	Viability test will be assessed by eosin-nigrosin staining technique

Trial Locations

Locations (2)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

Chulalongkorn University; 🇹🇭 Bangkok, Thailand