Royal Jelly Supplementation in Unexplained Male Infertility (NCT07337265) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Royal Jelly Supplementation in Unexplained Male Infertility
80 participantsStarted 2026-02-01
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sperm DNA Fragmentation Index (SDF)
Timeframe: Baseline (Day 0) and Post-treatment (Day 90)