Effect of Oral Royal Jelly Supplementation on Sperm DNA Fragmentation Index and Pregnancy in Couples With Unexplained Infertility: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Spontaneous Pregnancy Rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Royal Jelly
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
干预措施: Lyophilized Royal Jelly (Dietary Supplement)
Placebo Group
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days).
干预措施: Placebo (Other)
结局指标
主要结局
Spontaneous Pregnancy Rate
时间窗: Up to 3 months (90 days)
Number of couples achieving spontaneous pregnancy during the study period.
Change in Sperm DNA Fragmentation Index (SDF)
时间窗: 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
次要结局
- Serum Hormonal Profile(Baseline (Day 0) and Post-treatment (Day 90))
- Seminal Oxidative Stress Markers (TAS/TOS/OSI)(Baseline (Day 0) and Post-treatment (Day 90))
- Immunohistochemical Analysis (Exploratory)(Baseline (Day 0) and Post-treatment (Day 90))
- Sperm Chromatin Integrity(Baseline (Day 0) and Post-treatment (Day 90))
研究者
Ali Ihsan Memmi
medical doctor
Medipol University