Royal Jelly Supplementation in Unexplained Male Infertility
NCT07337265 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-01-13
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
Conditions
- Unexplained Infertility
- Male Infertility
- Sperm DNA Fragmentation
Interventions
- DIETARY_SUPPLEMENT
-
Lyophilized Royal Jelly
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
- OTHER
-
Placebo
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)
Sponsors & Collaborators
-
Medipol University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2026-07-01
- Completion
- 2026-08-01
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