Clinical trial NCT06560216: Cryopreservation Medium With Apigenin on Post-thaw Human Sperm
Official title: Effects of Supplementation of Cryopreservation Medium With Apigenin on Post-thaw Human Sperm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Apigenin
Cryopreservation
Antioxidant
Human sperm
Oxidative stress
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Frozen-thawed control without apigenin supplementation in freezing medium
2. Frozen-thawed sperm suspension with apigenin supplementation in freezing medium
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of sperm motility
timeFrame: At least 1 week of freezing
Secondary outcomes:
measure: Percentage of sperm viability comparison between intervention and control group
timeFrame: At least 1 week of freezing
Other outcomes:
measure: Total antioxidant capacity comparison between intervention and control group
timeFrame: At least 1 week of freezing
measure: Oxidative stress markers comparison between intervention and control group
timeFrame: At least 1 week of freezing
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Punyawee Utaipatanacheep
role: PRINCIPAL_INVESTIGATOR
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