An interventional study of Lyophilized Royal Jelly and Placebo in Unexplained Infertility, Male Infertility and Sperm DNA Fragmentation, sponsored by Medipol University. Recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
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
Infertility is a global health issue affecting approximately 15% of couples. "Unexplained Infertility" constitutes about 15-30% of these cases, where standard diagnostic tests (semen analysis, ovulation tests, and tubal patency) appear normal. Major factors contributing to the etiology of unexplained infertility include Sperm DNA Fragmentation (SDF) and Seminal Oxidative Stress (OS), which are not detected in routine spermiograms but can impair fertilization.
The European Association of Urology (EAU) guidelines suggest SDF testing in unexplained infertility cases, as high SDF rates reduce natural pregnancy chances and the success of assisted reproductive techniques. Royal Jelly, rich in 10-hydroxy-2-decenoic acid (10-HDA) and flavonoids, possesses potent antioxidant properties. While previous studies have shown that Royal Jelly improves sperm parameters, its efficacy specifically on DNA integrity in normozoospermic men with unexplained infertility remains unknown.
This prospective, randomized, double-blind, placebo-controlled study aims to investigate the protective effect of oral Royal Jelly supplementation on sperm DNA integrity and spontaneous pregnancy rates in men with unexplained infertility.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 187 interventional studies indexed under Infertility, Male.
Browse Infertility, Male studies →Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.
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Diagnosis of unexplained infertility with Normozoospermia according to WHO 2021 (6th Ed.) criteria:
Concentration ≥ 16 million/mL Total Motility ≥ 42% Progressive Motility ≥ 30% Normal Morphology (Kruger) ≥ 4% Female partner with normal gynecological evaluation (regular ovulation, normal ovarian reserve, and proven tubal patency via HSG).
Normal serum hormone levels (Testosterone, FSH, LH)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
Dietary Supplement: Lyophilized Royal Jelly
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days).
Other: Placebo
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)
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)
Spontaneous Pregnancy Rate
Number of couples achieving spontaneous pregnancy during the study period.
Time frame: Up to 3 months (90 days)
Serum Hormonal Profile
Measurement of serum Total Testosterone, FSH, and LH levels.
Time frame: Baseline (Day 0) and Post-treatment (Day 90)
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)
Sperm Chromatin Integrity
Assessment of chromatin integrity using Toluidine Blue staining.
Time frame: Baseline (Day 0) and Post-treatment (Day 90)
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)
Plan to share: Undecided
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