Male Infertility, Sperm DNA Fragmentation, Unexplained Infertility
Conditions
Keywords
royal jelly, unexplained male infertility, sperm dna fragmentation
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
Detailed 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.
Interventions
DIETARY_SUPPLEMENTLyophilized Royal Jelly
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
OTHERPlacebo
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sperm DNA Fragmentation Index (SDF) | 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 |
| Spontaneous Pregnancy Rate | Up to 3 months (90 days) | Number of couples achieving spontaneous pregnancy during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hormonal Profile | Baseline (Day 0) and Post-treatment (Day 90) | Measurement of serum Total Testosterone, FSH, and LH levels. |
| Seminal Oxidative Stress Markers (TAS/TOS/OSI) | 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. |
| Sperm Chromatin Integrity | Baseline (Day 0) and Post-treatment (Day 90) | Assessment of chromatin integrity using Toluidine Blue staining. |
| Immunohistochemical Analysis (Exploratory) | Baseline (Day 0) and Post-treatment (Day 90) | Evaluation of Mapk erk 1/2, Pten, and Mtor antibody expression in sperm samples. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAli İhsan Memmi
Outcome results
None listed