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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Royal Jelly | Experimental | Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days). |
|
| Placebo Group | Placebo Comparator | Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyophilized Royal Jelly | Dietary Supplement | Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sperm DNA Fragmentation Index (SDF) | DNA damage will be assessed using the HaloSperm to determine the percentage of spermatozoa with fragmented DNA | Baseline (Day 0) and Post-treatment (Day 90) |
| Spontaneous Pregnancy Rate | Number of couples achieving spontaneous pregnancy during the study period. | Up to 3 months (90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Hormonal Profile | Measurement of serum Total Testosterone, FSH, and LH levels. | Baseline (Day 0) and Post-treatment (Day 90) |
| Seminal Oxidative Stress Markers (TAS/TOS/OSI) | Evaluation of Total Antioxidant Status (TAS), Total Oxidant Status (TOS), and Oxidative Stress Index (OSI) using spectrophotometric analysis. |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali Ä°hsan Memmi | Contact | +90 537 922 0997 | alimemmi@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24799882 | Result | Amirshahi T, Najafi G, Nejati V. Protective effect of royal jelly on fertility and biochemical parameters in bleomycin-induced male rats. Iran J Reprod Med. 2014 Mar;12(3):209-16. | |
| 33422457 | Result | Tharakan T, Bettocchi C, Carvalho J, Corona G, Jones TH, Kadioglu A, Salamanca JIM, Serefoglu EC, Verze P, Salonia A, Minhas S; EAU Working Panel on Male Sexual Reproductive Health. European Association of Urology Guidelines Panel on Male Sexual and Reproductive Health: A Clinical Consultation Guide on the Indications for Performing Sperm DNA Fragmentation Testing in Men with Infertility and Testicular Sperm Extraction in Nonazoospermic Men. Eur Urol Focus. 2022 Jan;8(1):339-350. doi: 10.1016/j.euf.2020.12.017. Epub 2021 Jan 6. |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| Placebo | Other | Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days) |
|
| Baseline (Day 0) and Post-treatment (Day 90) |
| Sperm Chromatin Integrity | Assessment of chromatin integrity using Toluidine Blue staining. | Baseline (Day 0) and Post-treatment (Day 90) |
| Immunohistochemical Analysis (Exploratory) | Evaluation of Mapk erk 1/2, Pten, and Mtor antibody expression in sperm samples. | Baseline (Day 0) and Post-treatment (Day 90) |
| 31081299 | Result | Agarwal A, Parekh N, Panner Selvam MK, Henkel R, Shah R, Homa ST, Ramasamy R, Ko E, Tremellen K, Esteves S, Majzoub A, Alvarez JG, Gardner DK, Jayasena CN, Ramsay JW, Cho CL, Saleh R, Sakkas D, Hotaling JM, Lundy SD, Vij S, Marmar J, Gosalvez J, Sabanegh E, Park HJ, Zini A, Kavoussi P, Micic S, Smith R, Busetto GM, Bakircioglu ME, Haidl G, Balercia G, Puchalt NG, Ben-Khalifa M, Tadros N, Kirkman-Browne J, Moskovtsev S, Huang X, Borges E, Franken D, Bar-Chama N, Morimoto Y, Tomita K, Srini VS, Ombelet W, Baldi E, Muratori M, Yumura Y, La Vignera S, Kosgi R, Martinez MP, Evenson DP, Zylbersztejn DS, Roque M, Cocuzza M, Vieira M, Ben-Meir A, Orvieto R, Levitas E, Wiser A, Arafa M, Malhotra V, Parekattil SJ, Elbardisi H, Carvalho L, Dada R, Sifer C, Talwar P, Gudeloglu A, Mahmoud AMA, Terras K, Yazbeck C, Nebojsa B, Durairajanayagam D, Mounir A, Kahn LG, Baskaran S, Pai RD, Paoli D, Leisegang K, Moein MR, Malik S, Yaman O, Samanta L, Bayane F, Jindal SK, Kendirci M, Altay B, Perovic D, Harlev A. Male Oxidative Stress Infertility (MOSI): Proposed Terminology and Clinical Practice Guidelines for Management of Idiopathic Male Infertility. World J Mens Health. 2019 Sep;37(3):296-312. doi: 10.5534/wjmh.190055. Epub 2019 May 28. |
| D052801 |
| Male Urogenital Diseases |