Royal Jelly Supplementation in Unexplained Male Infertility

January 1, 2026 updated by: Ali Ihsan Memmi, Medipol University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Royal Jelly
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
Dietary supplement: Lyophilized Royal Jelly
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
Placebo Comparator: Placebo Group
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days).
Other: Placebo
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sperm DNA Fragmentation Index (SDF)
Time Frame: 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
Baseline (Day 0) and Post-treatment (Day 90)
Spontaneous Pregnancy Rate
Time Frame: Up to 3 months (90 days)
Number of couples achieving spontaneous pregnancy during the study period.
Up to 3 months (90 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Hormonal Profile
Time Frame: Baseline (Day 0) and Post-treatment (Day 90)
Measurement of serum Total Testosterone, FSH, and LH levels.
Baseline (Day 0) and Post-treatment (Day 90)
Seminal Oxidative Stress Markers (TAS/TOS/OSI)
Time Frame: 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.
Baseline (Day 0) and Post-treatment (Day 90)
Sperm Chromatin Integrity
Time Frame: Baseline (Day 0) and Post-treatment (Day 90)
Assessment of chromatin integrity using Toluidine Blue staining.
Baseline (Day 0) and Post-treatment (Day 90)
Immunohistochemical Analysis (Exploratory)
Time Frame: Baseline (Day 0) and Post-treatment (Day 90)
Evaluation of Mapk erk 1/2, Pten, and Mtor antibody expression in sperm samples.
Baseline (Day 0) and Post-treatment (Day 90)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 1, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123123123123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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