NCT07337265 Royal Jelly Supplementation in Unexplained Male Infertility
| NCT ID | NCT07337265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medipol University |
| Condition | Unexplained Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-02-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07337265 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 45 Years, studying Unexplained Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07337265 currently recruiting?
Yes, NCT07337265 is actively recruiting participants. Contact the research team at alimemmi@gmail.com for enrollment information.
Where is the NCT07337265 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07337265 clinical trial?
NCT07337265 is sponsored by Medipol University. The trial plans to enroll 80 participants.