Effect of Royal Jelly on Sperm Parameters and Sperm Functional Tests in Infertile Men with Increased Sperm DNA Fragmentation
Design
This study will be conducted on 12–18 infertile individuals with high sperm DNA damage. Participants will receive 1 g of royal jelly daily for 2 months, and sperm parameters, DNA damage, chromatin integrity, and oxidative stress will be evaluated before and after the intervention.
Settings and conduct
This before-and-after clinical trial investigates the effect of royal jelly on infertility in men with high sperm DNA damage. Written informed consent will be obtained from 12–18 participants who provide their sperm samples from the Shahrak Salamat Fertility Center.
Participants/Inclusion and exclusion criteria
The study included infertile men aged 35–55 years with primary infertility and high sperm DNA damage (SCSA > 20%), excluding azoospermic men and those with secondary infertility or lower DNA damage levels.
Intervention groups
Royal jelly, 1 g/day for 2 months (intervention group)
Main outcome variables
Sperm DNA integrity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110804007223N13
Registration date:2026-06-15, 1405/03/25
Registration timing:registered_while_recruiting
Last update:2026-06-15, 1405/03/25
Update count:0
Registration date
2026-06-15, 1405/03/25
Registrant information
Name
Mohammad Hossein Nasr-Esfahani
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Country
Iran (Islamic Republic of)
Phone
+98 31 9501 5688
Email address
mh_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-10, 1405/03/20
Expected recruitment end date
2026-09-11, 1405/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Royal Jelly on Sperm Parameters and Functional Tests in Infertile Men with Increased Sperm DNA Damage
Public title
Effect of Royal Jelly on Sperm Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile Men with Sperm DNA Damage Over 20%
Exclusion criteria:
Azoospermic Men
Infertile Men with Less Than 20% Sperm DNA Damage
Age
From 35 years old to 55 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
3
Semen
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Before-and-After Clinical Trial: In this study, variables in infertile men with high sperm DNA damage were examined before and after treatment with royal jelly.
All participants received royal jelly tablets at a daily dose of 1 g for 60 days. The tablets were manufactured by the Knowledge-Based Honey Jar Company.