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NCT Number: NCT07337265

Royal Jelly Supplementation in Unexplained Male Infertility

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

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Key information

Conditions

Unexplained Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Infertility Male Urogenital Diseases Sperm DNA Fragmentation Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lyophilized Royal Jelly

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Change in Sperm DNA Fragmentation Index (SDF)

    Time frame: 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

  2. Spontaneous Pregnancy Rate

    Time frame: Up to 3 months (90 days)

    Number of couples achieving spontaneous pregnancy during the study period.

Secondary outcomes

  1. Serum Hormonal Profile

    Time frame: Baseline (Day 0) and Post-treatment (Day 90)

    Measurement of serum Total Testosterone, FSH, and LH levels.

  2. Seminal Oxidative Stress Markers (TAS/TOS/OSI)

    Time frame: Baseline (Day 0) and Post-treatment (Day 90)

    Evaluation of Total Antioxidant Status (TAS), Total Oxidant Status (TOS), and Oxidative Stress Index (OSI) using spectrophotometric analysis.

  3. Sperm Chromatin Integrity

    Time frame: Baseline (Day 0) and Post-treatment (Day 90)

    Assessment of chromatin integrity using Toluidine Blue staining.

  4. Immunohistochemical Analysis (Exploratory)

    Time frame: Baseline (Day 0) and Post-treatment (Day 90)

    Evaluation of Mapk erk 1/2, Pten, and Mtor antibody expression in sperm samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali İhsan Memmi

CONTACT

[email protected]

+90 537 922 0997

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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