Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

NCT ID: NCT06560216

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2025-03-03

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Frozen-thawed sperm suspension without apigenin supplementation in freezing medium

Group Type: NO_INTERVENTION

No interventions assigned to this group

Apigenin

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

Group Type: EXPERIMENTAL

Apigenin

Intervention Type: DIETARY_SUPPLEMENT

0.2 mM in freezing medium

Interventions

Apigenin

0.2 mM in freezing medium

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Punyawee Utaipatanacheep

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

Chulalongkorn Hospital

Bangkok, , Thailand

Chulalongkorn University

Bangkok, , Thailand

Countries

Thailand

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Other Identifiers

062267

Identifier Type: -

Identifier Source: org_study_id