NCT07337265

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 1, 2026

Last Update Submit

January 1, 2026

Conditions

Male InfertilityUnexplained InfertilitySperm DNA Fragmentation

Keywords

royal jellyunexplained male infertilitysperm dna fragmentation

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (4)

  • Serum Hormonal Profile

    Baseline (Day 0) and Post-treatment (Day 90)

  • Seminal Oxidative Stress Markers (TAS/TOS/OSI)

    Baseline (Day 0) and Post-treatment (Day 90)

  • Sperm Chromatin Integrity

    Baseline (Day 0) and Post-treatment (Day 90)

  • Immunohistochemical Analysis (Exploratory)

    Baseline (Day 0) and Post-treatment (Day 90)

Study Arms (2)

Royal Jelly

EXPERIMENTAL

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

Dietary Supplement: Lyophilized Royal Jelly

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lyophilized Royal JellyDIETARY_SUPPLEMENT

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

Royal Jelly
PlaceboOTHER

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

Placebo Group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 24799882RESULT

  • 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.

    PMID: 33422457RESULT

  • 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.

    PMID: 31081299RESULT

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Central Study Contacts

Ali İhsan Memmi

CONTACT

+90 537 922 0997alimemmi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 13, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01