Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

March 16, 2025 updated by: Chulalongkorn University

Effects of Supplementation of 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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Frozen-thawed sperm suspension without apigenin supplementation in freezing medium
Experimental: Apigenin
Frozen-thawed sperm suspension with apigenin 0.2 mM supplementation in freezing medium
Dietary supplement: Apigenin
0.2 mM in freezing medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At least 1 week of freezing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At least 1 week of freezing

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At least 1 week of freezing
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
At least 1 week of freezing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Punyawee Utaipatanacheep, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Actual)

February 12, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 062267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

You can ask for information directly from the investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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