Royal Jelly Supplementation in Unexplained Male Infertility

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Lyophilized Royal Jelly
  Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
• Другое Placebo
  Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)

Первичные конечные точки

• Change in Sperm DNA Fragmentation Index (SDF) [Срок оценки: Baseline (Day 0) and Post-treatment (Day 90)]
• Spontaneous Pregnancy Rate [Срок оценки: Up to 3 months (90 days)]

Вторичные конечные точки (4)

• Serum Hormonal Profile [Срок оценки: Baseline (Day 0) and Post-treatment (Day 90)]
• Seminal Oxidative Stress Markers (TAS/TOS/OSI) [Срок оценки: Baseline (Day 0) and Post-treatment (Day 90)]
• Sperm Chromatin Integrity [Срок оценки: Baseline (Day 0) and Post-treatment (Day 90)]
• Immunohistochemical Analysis (Exploratory) [Срок оценки: Baseline (Day 0) and Post-treatment (Day 90)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 24799882
• 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 Testi PMID 33422457
• 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-B PMID 31081299

Идентификаторы

NCT: NCT07337265 · 123123123123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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