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AzTrials

HealthyNCT06560216

Cryopreservation Medium With Apigenin on Post-thaw Human Sperm

A study testing Apigenin in people with Healthy, run by Chulalongkorn University at 2 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Apigenin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
2 sitesThailand
Study dates
28 Oct 2024to 3 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Chulalongkorn University

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: 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?
Read the 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
Being tested
Apigenin
Keywords
Apigenin, Cryopreservation, Antioxidant, Human sperm, Oxidative stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApigeninDietary supplement

    0.2 mM in freezing medium

Study groups in NCT06560216
Study groupRoleWhat they receive
ControlNo interventionFrozen-thawed sperm suspension without apigenin supplementation in freezing medium
ApigeninExperimentalFrozen-thawed sperm suspension with apigenin 0.2 mM supplementation in freezing medium
Receives: Dietary Supplement: Apigenin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At least 1 week of freezing

Secondary outcomes (1)

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

    Viability test will be assessed by eosin-nigrosin staining technique

    Measured: At least 1 week of freezing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start28 Oct 2024
  3. Primary completion12 Feb 2025
  4. Study completion3 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
1. Frozen-thawed control without apigenin supplementation in freezing medium 2. Frozen-thawed sperm suspension with apigenin supplementation in freezing medium
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560216
Sponsor's protocol ID
062267
Status last verified
Oct 2024
First submitted
15 Aug 2024
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: You can ask for information directly from the investigators.

Publications

  • PubChem [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. PubChem Compound Summary for CID 5280443, Apigenin; [cited 2024 July 25]. [Internet]. 2004. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Apigenin.

  • World Health Organization. WHO laboratory manual for the examination and processing of human semen. 6th ed. Geneva: World Health Organization, Cop; 2021.

  • Ngamjarus C, Pattanittum P. n4Studies: application for sample size calculation in health science research. Version 2.3. App store. 2024.

  • Ngamjarus C. Sample size calculation for health science research. 1st ed. Khon Kaen University Printing House, Khon Kaen, Thailand 2021.

  • Chow S-C, Shao J, Wang H. Sample size calculations in clinical research. 2 ed. Boca Raton: FLA: Chapman and Hall/CRC; 2003.

  • Anger JT, Gilbert BR, Goldstein M. Cryopreservation of sperm: indications, methods and results. J Urol. 2003 Oct;170(4 Pt 1):1079-84. doi: 10.1097/01.ju.0000084820.98430.b8.

    PubMed 14501696

  • Sharma Y, Sharma M. Sperm Cryopreservation: Principles and Biology. J Infertil Reprod Biol 2020;8:43-8.

  • Hai E, Li B, Zhang J, Zhang J. Sperm freezing damage: the role of regulated cell death. Cell Death Discov. 2024 May 18;10(1):239. doi: 10.1038/s41420-024-02013-3.

    PubMed 38762505

  • Keel BA, Black JB. Reduced motility longevity in thawed human spermatozoa. Arch Androl. 1980 May;4(3):213-5. doi: 10.3109/01485018008986965.

    PubMed 7416844

  • O'Connell M, McClure N, Lewis SE. The effects of cryopreservation on sperm morphology, motility and mitochondrial function. Hum Reprod. 2002 Mar;17(3):704-9. doi: 10.1093/humrep/17.3.704.

    PubMed 11870124

  • Ozkavukcu S, Erdemli E, Isik A, Oztuna D, Karahuseyinoglu S. Effects of cryopreservation on sperm parameters and ultrastructural morphology of human spermatozoa. J Assist Reprod Genet. 2008 Aug;25(8):403-11. doi: 10.1007/s10815-008-9232-3. Epub 2008 Aug 13.

    PubMed 18704674

  • Oberoi B, Kumar S, Talwar P. Study of human sperm motility post cryopreservation. Med J Armed Forces India. 2014 Oct;70(4):349-53. doi: 10.1016/j.mjafi.2014.09.006. Epub 2014 Oct 16.

    PubMed 25382909

  • Liu T, Gao J, Zhou N, Mo M, Wang X, Zhang X, Yang H, Chen Q, Ao L, Liu J, Cui Z, Cao J. The effect of two cryopreservation methods on human sperm DNA damage. Cryobiology. 2016 Jun;72(3):210-5. doi: 10.1016/j.cryobiol.2016.04.004. Epub 2016 Apr 25.

    PubMed 27126062

  • Hezavehei M, Sharafi M, Kouchesfahani HM, Henkel R, Agarwal A, Esmaeili V, Shahverdi A. Sperm cryopreservation: A review on current molecular cryobiology and advanced approaches. Reprod Biomed Online. 2018 Sep;37(3):327-339. doi: 10.1016/j.rbmo.2018.05.012. Epub 2018 Aug 22.

    PubMed 30143329

  • Darsini N, Hamidah B, Suyono S, Ashari F, Aswin R, Yudiwati R. Human Sperm Motility, Viability, and Morphology Decreased after Cryopreservation. Folia Medica Indonesiana 2019;55:198.

Questions about this trial

What is this clinical trial studying?

A study testing Apigenin in people with Healthy, run by Chulalongkorn University at 2 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of sperm motility (time frame: At least 1 week of freezing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560216, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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