Royal Jelly Supplementation in Unexplained Male Infertility

Medipol University

Status: Not yet enrolling

Conditions: Sperm DNA Fragmentation; Male Infertility; Unexplained Infertility

Treatments: Dietary Supplement: Lyophilized Royal Jelly; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07337265

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Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Royal Jelly

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lyophilized Royal Jelly

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo