Royal Jelly Supplementation in Unexplained Male Infertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorMedipol University
About this trial
This randomized, double-blind, placebo-controlled clinical trial investigates the effects of oral Royal Jelly supplementation on sperm DNA fragmentation and pregnancy rates in couples with unexplained infertility. While routine semen analysis appears normal (normozoospermia) in these patients, underlying Sperm DNA Fragmentation (SDF) and oxidative stress are believed to contribute to reproductive failure.
Participants will be randomized to receive either 750 mg of lyophilized Royal Jelly or a placebo daily for a period of 3 months (90 days). The study aims to evaluate whether the antioxidant properties of Royal Jelly can improve sperm chromatin integrity, reduce oxidative stress markers, and increase spontaneous pregnancy rates compared to the control group
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men aged 18-45 years. History of infertility for at least 1 year despite unprotected intercourse.
Disqualifiers
Any abnormality in spermiogram (Oligo-, Asteno-, or Teratozoospermia). Presence of clinical varicocele. Leukocytospermia (>1 million/mL) or active infection. History of smoking (>5 cigarettes/day) or BMI > 30 kg/m². Use of any antioxidant supplementation within the last 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Lyophilized Royal Jelly
Dietary supplementParticipants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
Placebo
Other interventionParticipants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Royal JellyExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Sperm DNA Fragmentation Index (SDF)
DNA damage will be assessed using the HaloSperm to determine the percentage of spermatozoa with fragmented DNA
Time frame
Baseline (Day 0) and Post-treatment (Day 90)2
Spontaneous Pregnancy Rate
Number of couples achieving spontaneous pregnancy during the study period.
Time frame
Up to 3 months (90 days)Secondary outcomes
1
Serum Hormonal Profile
Measurement of serum Total Testosterone, FSH, and LH levels.
Time frame
Baseline (Day 0) and Post-treatment (Day 90)2
Seminal Oxidative Stress Markers (TAS/TOS/OSI)
Evaluation of Total Antioxidant Status (TAS), Total Oxidant Status (TOS), and Oxidative Stress Index (OSI) using spectrophotometric analysis.
Time frame
Baseline (Day 0) and Post-treatment (Day 90)3
Sperm Chromatin Integrity
Assessment of chromatin integrity using Toluidine Blue staining.
Time frame
Baseline (Day 0) and Post-treatment (Day 90)4
Immunohistochemical Analysis (Exploratory)
Evaluation of Mapk erk 1/2, Pten, and Mtor antibody expression in sperm samples.
Time frame
Baseline (Day 0) and Post-treatment (Day 90)Sponsors and contacts
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Source ClinicalTrials.gov