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Clinical Trials in Turkey / NCT07337265
Recruiting Not applicable

Royal Jelly Supplementation in Unexplained Male Infertility

NCT07337265 · tracked via the Priya Life Science Turkey tracker
Sponsor
Medipol University
Phase
Not applicable
Started
2026-02-01
Last updated
2026-08-19

Condition(s) studied

Unexplained InfertilityMale InfertilitySperm DNA Fragmentation

Investigational drug(s) / intervention(s)

Lyophilized Royal JellyPlacebo

Lyophilized Royal Jelly: Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).

Placebo: Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)

Study summary

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

Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in Sperm DNA Fragmentation Index (SDF) — Baseline (Day 0) and Post-treatment (Day 90)
    DNA damage will be assessed using the HaloSperm to determine the percentage of spermatozoa with fragmented DNA
  • Spontaneous Pregnancy Rate — Up to 3 months (90 days)
    Number of couples achieving spontaneous pregnancy during the study period.

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medipol University Istanbul Başakşehir Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07337265 on ClinicalTrials.gov ↗ ← All trials in Turkey