Azoospermia, NonobstructivePhase 1/2MARSNCT06869863
Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®
A Phase 1/2 study testing Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders and Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months. in people with Azoospermia, Nonobstructive and Teratospermia, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
Trial summary
The study is open to patients with severe forms of male infertility (non-obstructive disorders of spermatogenesis, including azoospermia). The Phase I/II clinical trial is being conducted at the Lomonosov Moscow State University and is aimed at studying the efficacy and safety of the innovative drug "MediReg® (Human… Read more about this study
- Who is it for?
- Ages 21 to 60 years, men only
- Conditions the study is for
- Azoospermia, Nonobstructive, Teratospermia, Oligospermia
- What is being tested?
- Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders and Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 26 Nov 2024to Dec 2025
- Phase
- Phase 1/2
- 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 21 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Male patients aged 21-60 years at the time of inclusion in the study. 2. Persistent severe disorders of spermatogenesis, manifested as severe oligoasthenoteratozoospermia (OAT)*, non-obstructive azoospermia, high sperm DNA fragmentation (30% or more), including those caused by secretory infertility according to dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).
- "Persistent severe OAT" should be considered as disorders when sperm concentration <5 million/mL, progressively motile sperm <13% and/or total number of progressively motile sperm in the ejaculate (PMPM) <5 million, with the proportion of normal sperm <1% according to the dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).
- 3. inability to conceive against the background of "severe forms" of male infertility, not amenable to treatment, including assisted reproductive technologies, within 12 months from the moment of diagnosis or refusal to use assisted reproductive technologies.
- 4. Voluntarily signed Informed consent by the patient to participate in the clinical trial.
- 5. Willingness of patients and their sexual partners to use reliable contraceptive methods (combination of at least 2 methods, including 1 barrier method, e.g., use of spermicide and condom) from the time of signing the informed consent until at least 1 month after completion of study participation.
- 6. Patient willingness to follow all the requirements of the Protocol.
Who cannot join
- 1. Age younger than 21 and older than 60 years at the time of inclusion in the study.
- 2. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).
- 3. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive technologies. 4.
- 4. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.
- 5. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectious diseases (including STDs) of the urinary and/or reproductive system.
- 7. Hereditary factors of infertility: (Klinefelter syndrome (all variants), autosomal abnormalities (all variants), carrying the cystic fibrosis gene (all variants), presence of Y-chromosome microdeletions (all AZF variants), autosomal defects with severe phenotypic abnormalities and infertility (Prader-Willi, Bardet-Biedl, Noonan syndromes, myotonic dystrophy, dominant polycystic kidney disease, 5-alpha-reductase enzyme deficiency, etc.). д.).
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- 8. Obstructive azoospermia by history or established by screening examination. 9. Positive test for HIV, hepatitis B and C, syphilis. 10. Severe liver failure or active liver disease (transaminase activity exceeding 5 times the upper limit of the local laboratory norm).
- 11. Renal dysfunction with serum creatinine levels exceeding 120 µmol/L. 12. Cardiovascular diseases in the history within 6 months before inclusion in the study, such as myocardial infarction, angina pectoris, severe ventricular arrhythmia, heart failure (NYHA class II-IV).
- 13. Neurologic (Parkinson's disease) and/or psychiatric illnesses with a history or established by screening examination.
- 14. Cancer with a history of cancer or as determined by screening examination (as determined by OBP and renal ultrasound, bladder ultrasound, prostate TRUS).
- 15. Hypersensitivity to any of the components of the study drug in the history. 16. Mental illness, severe cognitive impairment, need to take tranquilizers, neuroleptics and/or antidepressants during this study.
- 17. Severe somatic illnesses that, in the opinion of the investigator, may affect the patient's safety and ability to comply with the Protocol.
- 18. A history of drug dependence. 19. Positive urinalysis for psychotropic and narcotic drugs, psychoactive medications.
- 20. Intake of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 1⁄2 liter of beer, 200 ml of wine, or 50 ml of alcohol) or a history of alcoholism.
- 21. Detection of alcohol vapor in breath 22. Participation in another clinical trial currently or in the previous 30 days prior to the screening visit.
- 23. Patient's inability to understand or comply with study procedures or patient's refusal to cooperate with a particular investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov
Moscow, Moscow, 119234
Julia Begrambekova, PHD, +79854679273, julia.begrambekova@ossn.ru
About this study
Official title: Open Single-center Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg® (Human Mesenchymal Stromal Cell Secretome), Lyophilizate for Preparation of Solution for Injection in Patients with Severe Spermatogenesis Disorders
The study is open to patients with severe forms of male infertility (non-obstructive disorders of spermatogenesis, including azoospermia).
The Phase I/II clinical trial is being conducted at the Lomonosov Moscow State University and is aimed at studying the efficacy and safety of the innovative drug "MediReg® (Human Mesenchymal Stromal Cell Secretome)", lyophilizate for preparation of solution for injection, 1.0 ml/dose for treatment of male infertility. The study was approved by the Ministry of Health of the Russian Federation. The study is planned to include men aged 21 to 60 years with severe spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more) and faced with the inability to conceive, including with the help of assisted reproductive technologies within 12 months from the date of diagnosis The aim of the therapy is to improve the spermogram indicators in order to increase the chances of successful use of assisted reproductive technologies.
Read more
The drug is injected once under the protein sheath of both testicles. Observation in 1 week after the drug administration is carried out in hospital. Follow-up is performed by outpatient visits to the research center.
The clinical trial is planned to enroll at least 80 adult patients aged 21 to 60 years with severe spermatogenesis disorders The study will include 3 periods:Screening Period - Day -15...0.
, Period of study drug administration and inpatient follow-up - Day 1 through Day 7., Follow-up period - through Day 90.
The total duration of participation in the study, including the screening period and the follow-up period, will not exceed 119 days. After the end of the study period, the study will be followed up for 1 year to record delayed adverse events.
- Being tested
- Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders, Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.
- Keywords
- men infertility, azoospermia
- Medical subject headings
- Azoospermia, Nonobstructive, Teratozoospermia, Oligospermia, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disordersBiological
Human mesenchymal stromal cell secretion1 containing vascular endothelial growth factor (VEGF)2 ≥ 5,0 нг
Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.Other
Combination treatment recommended by standards
| Study group | Role | What they receive |
|---|---|---|
| MediReg | Experimental | 60 patients (20 patients in first phase of the study and 60 patients in 2nd phase) a single injection of 0.5 ml of the investigational drug intratesticularly under the white membrane, alternately in both testicles Receives: Biological: Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders |
| Clomiphene /Triovit,/Folic acid | Active comparator | Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months. Receives: Other: Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen Analysis
In more than 30% of patients with nonobstructive azoospermia appearance of sperm cells in semen
Measured: 90 days
Secondary outcomes (1)
Increase in inhibin B level by more than 20% from baseline
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start26 Nov 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Azoospermia, NonobstructiveStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, prospective, open-label, uncontrolled phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection will be performed in patients with severe forms of spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more). The absence of a comparison group is due to the fact that participation in the study carries a risk to patients that exceeds the minimum risk, Out of 60 patients, 20 subjects will be treated with MediReg® with evaluation of pharmacokinetics before and after drug administration. To confirm the non-randomization of the recorded changes, a control group receives therapy according to the approved recommendations, spermogram and hormonal profile assessment on days 0...90 is provided
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitry Okhobotov, doctor of sciences, Principal investigator, University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow,Anastasia Efimenko, doctor of sciences, Study chair, University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow, Moscow 119234
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869863
- Sponsor's protocol ID
- MSU 001
- Acronym
- MARS
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Single-center Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg® (Human Mesenchymal Stromal Cell Secretome), Lyophilizate for Preparation of Solution for Injection in Patients with Severe Spermatogenesis Disorders
- ClinicalTrials.gov ID
- NCT06869863
- Acronym / sponsor ID
- MARS / MSU 001
- Keywords
- men infertility, azoospermia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational CenterUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
The study is open to patients with severe forms of male infertility (non-obstructive disorders of spermatogenesis, including azoospermia).
The Phase I/II clinical trial is being conducted at the Lomonosov Moscow State University and is aimed at studying the efficacy and safety of the innovative drug "MediReg® (Human Mesenchymal Stromal Cell Secretome)", lyophilizate for preparation of solution for injection, 1.0 ml/dose for treatment of male infertility. The study was approved by the Ministry of Health of the Russian Federation. The study is planned to include men aged 21 to 60 years with severe spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more) and faced with the inability to conceive, including with the help of assisted reproductive technologies within 12 months from the date of diagnosis The aim of the therapy is to improve the spermogram indicators in order to increase the chances of successful use of assisted reproductive technologies.
The drug is injected once under the protein sheath of both testicles. Observation in 1 week after the drug administration is carried out in hospital. Follow-up is performed by outpatient visits to the research center.
The clinical trial is planned to enroll at least 80 adult patients aged 21 to 60 years with severe spermatogenesis disorders The study will include 3 periods:Screening Period - Day -15...0.
, Period of study drug administration and inpatient follow-up - Day 1 through Day 7., Follow-up period - through Day 90.
The total duration of participation in the study, including the screening period and the follow-up period, will not exceed 119 days. After the end of the study period, the study will be followed up for 1 year to record delayed adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, prospective, open-label, uncontrolled phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection will be performed in patients with severe forms of spermatogenesis disorders manifested as severe oligoasthenoteratozoospermia (OAT), non-obstructive azoospermia, high sperm DNA fragmentation (30% and more). The absence of a comparison group is due to the fact that participation in the study carries a risk to patients that exceeds the minimum risk, Out of 60 patients, 20 subjects will be treated with MediReg® with evaluation of pharmacokinetics before and after drug administration. To confirm the non-randomization of the recorded changes, a control group receives therapy according to the approved recommendations, spermogram and hormonal profile assessment on days 0...90 is provided
| Arm | Type | Receives |
|---|---|---|
| MediReg | Experimental | Biological: Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders60 patients (20 patients in first phase of the study and 60 patients in 2nd phase) a single injection of 0.5 ml of the investigational drug intratesticularly under the white membrane, alternately in both testicles |
| Clomiphene /Triovit,/Folic acid | Active comparator | Other: Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Male patients aged 21-60 years at the time of inclusion in the study. 2. Persistent severe disorders of spermatogenesis, manifested as severe oligoasthenoteratozoospermia (OAT)*, non-obstructive azoospermia, high sperm DNA fragmentation (30% or more), including those caused by secretory infertility according to dynamic control of spermogram (at least 12 months from the moment of inclusion in the study).
- 3. inability to conceive against the background of "severe forms" of male infertility, not amenable to treatment, including assisted reproductive technologies, within 12 months from the moment of diagnosis or refusal to use assisted reproductive technologies.
- 4. Voluntarily signed Informed consent by the patient to participate in the clinical trial.
- 5. Willingness of patients and their sexual partners to use reliable contraceptive methods (combination of at least 2 methods, including 1 barrier method, e.g., use of spermicide and condom) from the time of signing the informed consent until at least 1 month after completion of study participation.
- 6. Patient willingness to follow all the requirements of the Protocol.
Key exclusion criteria (16 listed)
- 1. Age younger than 21 and older than 60 years at the time of inclusion in the study.
- 2. developmental anomalies of the genitourinary system (according to bladder and kidney ultrasound).
- 3. surgical interventions on genitourinary organs in the history, except for surgical interventions associated with assisted reproductive technologies. 4.
- 4. Systemic diseases requiring administration of corticosteroids, cytostatics, radiation therapy.
- 5. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectious diseases (including STDs) of the urinary and/or reproductive system.
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 |
|---|---|---|
| Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disordersHuman mesenchymal stromal cell secretion1 containing vascular endothelial growth factor (VEGF)2 ≥ 5,0 нг | Biological | MediReg |
| Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months.Combination treatment recommended by standards | Other | Clomiphene /Triovit,/Folic acid |
Primary outcome
Semen Analysis
Time frame: 90 days
In more than 30% of patients with nonobstructive azoospermia appearance of sperm cells in semen
1 secondary outcome
Increase in inhibin B level by more than 20% from baseline
Time frame: 90 days
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 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Dmitry Okhobotov, doctor of sciences principal investigator
University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow,
Anastasia Efimenko, doctor of sciences study chair
University Clinic of the Medical Scientific and Educational Institute of Moscow State University named after M.V.Lomonosov, Moscow, Moscow 119234
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Medicinal product MediReg® (Human Mesenchymal Stromal Cell Secretome), lyophilizate for preparation of solution for injection in patients with severe spermatogenesis disorders and Clostilbegit (clomiphene) 50 mg 1 tablet x 1 p a day - 3 months, Triovit - 1 tablet x 1 p a day - 3 months, Folic acid - 1 tablet x 1 p a day - 3 months. in people with Azoospermia, Nonobstructive and Teratospermia, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
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 6 inclusion and 16 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 11 Mar 2025. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Julia Begrambekova, Phd (+79854679273, julia.begrambekova@ossn.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen Analysis (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.