Unexplained InfertilityNCT07337265
Royal Jelly Supplementation in Unexplained Male Infertility
A study testing Lyophilized Royal Jelly in people with Unexplained Infertility and Male Infertility, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Unexplained Infertility, Male Infertility, Sperm DNA Fragmentation
- What is being tested?
- Lyophilized Royal Jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Başakşehir, 34100
Ali ihsan Memmi, MD, 905379220997, alimemmi@gmail.com
About this study
Official title: 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
Read the 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.
- Being tested
- Lyophilized Royal Jelly, Placebo
- Keywords
- royal jelly, unexplained male infertility, sperm dna fragmentation
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized Royal JellyDietary supplement
Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days).
PlaceboOther
Participants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days)
| Study group | Role | What they receive |
|---|---|---|
| Royal Jelly | Experimental | Participants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sperm DNA Fragmentation Index (SDF)
DNA damage will be assessed using the HaloSperm to determine the percentage of spermatozoa with fragmented DNA
Measured: Baseline (Day 0) and Post-treatment (Day 90)
Spontaneous Pregnancy Rate
Number of couples achieving spontaneous pregnancy during the study period.
Measured: Up to 3 months (90 days)
Secondary outcomes (4)
Serum Hormonal Profile
Measurement of serum Total Testosterone, FSH, and LH levels.
Measured: 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.
Measured: Baseline (Day 0) and Post-treatment (Day 90)
Sperm Chromatin Integrity
Assessment of chromatin integrity using Toluidine Blue staining.
Measured: 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.
Measured: Baseline (Day 0) and Post-treatment (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ihsan Memmi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337265
- Sponsor's protocol ID
- 123123123123
- Status last verified
- Jul 2026
- First submitted
- 1 Jan 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24799882Tharakan 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.
PubMed 33422457Agarwal 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.
PubMed 31081299
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07337265
- Acronym / sponsor ID
- 123123123123
- Keywords
- royal jelly, unexplained male infertility, sperm dna fragmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Royal Jelly | Experimental | Dietary Supplement: Lyophilized Royal JellyParticipants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days). |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized Royal JellyParticipants will receive 750 mg of Lyophilized Royal Jelly capsules daily for 3 months (90 days). | Dietary supplement | Royal Jelly |
| PlaceboParticipants will receive inert capsules identical in appearance and taste to the experimental drug daily for 3 months (90 days) | Other | Placebo Group |
Primary outcome
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
Spontaneous Pregnancy Rate
Time frame: Up to 3 months (90 days)
Number of couples achieving spontaneous pregnancy during the study period.
4 secondary outcomes
Serum Hormonal Profile
Time frame: 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)
Sperm Chromatin Integrity
Time frame: Baseline (Day 0) and Post-treatment (Day 90)
Immunohistochemical Analysis (Exploratory)
Time frame: Baseline (Day 0) and Post-treatment (Day 90)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 24799882Amirshahi 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.
- Results publication: PubMed 33422457Tharakan 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.
- Results publication: PubMed 31081299Agarwal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyophilized Royal Jelly in people with Unexplained Infertility and Male Infertility, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali İhsan Memmi (+90 537 922 0997, alimemmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sperm DNA Fragmentation Index (SDF) (time frame: Baseline (Day 0) and Post-treatment (Day 90)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337265, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.