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RECRUITING Not applicable ClinicalTrials.gov

Royal Jelly Supplementation in Unexplained Male Infertility

Sponsor: Medipol University • ClinicalTrials.gov ID: NCT07337265

Registry updated: 2026-08-19
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Description

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

Interventions

  • Lyophilized Royal Jelly (Dietary supplement)
    Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
  • Placebo (Other)
    Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)

Eligibility criteria

Inclusion Criteria: * Men aged 18-45 years. History of infertility for at least 1 year despite unprotected intercourse. 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: * 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.

Conditions

Unexplained Infertility Male Infertility Sperm DNA Fragmentation

Locations

  • Istanbul Medipol University — Istanbul, Başakşehir, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record