AzoospermiaPhase 2NCT03762967
Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility
A Phase 2 study testing Lipoaspiration and SVF introduction. and Standard therapy. in people with Azoospermia and Oligozoospermia, run by State-Financed Health Facility "Samara Regional Medical Center Dinasty" at 1 site in Russia.
Trial summary
Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is a common finding in male infertility. Often semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility that affect Male fertility. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Azoospermia, Oligozoospermia
- What is being tested?
- Lipoaspiration and SVF introduction. and Standard therapy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 12 Mar 2018to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- idiopathic oligozoospermia (spermatozoid number <2x10^6/mL) - 10 patients
- cryptozoospermia/azoospermia - 10 patients
Who cannot join
- age before 18 or after 60 years old
- heart insufficiency. stroke (during 1 year)
- anemia
- blood disease
- pelvis bone trauma
- chronic diseases in decompensation stage
Show all 16Show fewer
- skin diseases
- tuberculosis
- hyperprolactinaemia
- hyper or hypothyreosis
- obstructive zoospermia
- sperm stimulating hormone therapy
- Men with previous surgery in testis
- Men with infectious genital diseases and anatomical abnormalities of the genital tract
- Those with major medical problems such as malignancy, hepatitis B . C, etc. HIV
- Chromosomal aberration (e.g. Y microdeletion, trisomy….)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.
Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is a common finding in male infertility. Often semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility that affect Male fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and affect male fertility.
Read the detailed description
This is an open-label study to evaluate efficiency of administration of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with oligospermia and azoospermia.
Forty men with several form oligozoospermia and azoospermia will be recruited for the study. 20 patients with same diagnosis served as a control with standard medications.Other patients -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF injections.
The diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more semen analysis evaluations done at separate occasions and detailed history taking, physical examination and investigations (blood tests include hormon levels as testosteron. follicle stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated.
This study affect only Pretesticular and Testicular forms, without chromosomal aberration. SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF, Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover the microvesicles and exosomes released by this cells can prevent cells from apoptosis and stimulate regenerative process of surrounding tissues and cells.
SVF will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after cell injection.
- Conditions
- Azoospermia, Oligozoospermia
- Being tested
- Lipoaspiration and SVF introduction., Standard therapy.
- Keywords
- Autologous Stem Cell, Male infertility, Adipose-Derived stem cell, Azoospermia, Oligospermia
- Medical subject headings
- Azoospermia, Oligospermia, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoaspiration and SVF introduction.Biological
Lipoaspiration, isolation of SVF and introduction into testis Interstitium.
Standard therapy.Drug
Also called healthy diet, physical exertion eliminate. hormone therapy.
Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Lipoaspiration and SVF introduction I. | Experimental | Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction. Receives: Biological: Lipoaspiration and SVF introduction.; Drug: Standard therapy. |
| Standard therapy I. | Active comparator | Patients with azoospermia that introduce with Standard therapy only. Receives: Drug: Standard therapy. |
| Lipoaspiration and SVF introduction II | Experimental | Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction. Receives: Biological: Lipoaspiration and SVF introduction.; Drug: Standard therapy. |
| Standard therapy II. | Active comparator | Patients with oligospermia that introduce with Standard therapy only. Receives: Drug: Standard therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm concentration in ejaculate
Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.
Measured: 1, 2, 3 month
Spermatozoa in testicular biopsy
Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
Measured: 3 month
Secondary outcomes (3)
Testosterone
Testosterone will be measured a three month after injection of SVF.
Measured: 3 month
Inhibin-B
Inhibin-B will be measured a three month after injection of SVF.
Measured: 3 month
Follicle stimulating hormone (FSH)
Follicle stimulating hormone will be measured a three month after injection of SVF.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start12 Mar 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AzoospermiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State-Financed Health Facility "Samara Regional Medical Center Dinasty"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volchkov Stanislav, State-Financed Health Facility "Samara Regional Medical Center Dinasty"
- Investigators
- Olga Tyumina, M.D. P.h.D., Study chair, Medical Centre Dinasty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762967
- Sponsor's protocol ID
- 23032018
- Status last verified
- Oct 2020
- First submitted
- 27 Nov 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.
- ClinicalTrials.gov ID
- NCT03762967
- Acronym / sponsor ID
- 23032018
- Conditions
- Azoospermia, Oligozoospermia
- Keywords
- Autologous Stem Cell, Male infertility, Adipose-Derived stem cell, Azoospermia, Oligospermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- State-Financed Health Facility "Samara Regional Medical Center Dinasty"University, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Dec 2018 (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.
Severe Oligospermia (oligozoospermia) refer to semen with a low concentration of sperm and is a common finding in male infertility. Often semen with a decreased sperm concentration may also show significant abnormalities in sperm morphology and motility that affect Male fertility. The purpose of this study is to assess the ability of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) cells to stimulate Sertoli and spermatogonia cells and affect male fertility.
Detailed description
This is an open-label study to evaluate efficiency of administration of Autologous Adipose-Derived Adult Stromal Vascular Fraction (SVF) in the testis in patients with oligospermia and azoospermia.
Forty men with several form oligozoospermia and azoospermia will be recruited for the study. 20 patients with same diagnosis served as a control with standard medications.Other patients -10 with oligospermia and 10 with azoospermia will receive standard medication and SVF injections.
The diagnosis of Azoospermia (Oligospermia) will be established on the basis of two and more semen analysis evaluations done at separate occasions and detailed history taking, physical examination and investigations (blood tests include hormon levels as testosteron. follicle stimulating hormone (FSH), luteinizing hormone (LH). karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated.
This study affect only Pretesticular and Testicular forms, without chromosomal aberration. SVF can produce a lot of cytokines ( as EGF, FGF, NGF, PDGF, VEGF, IGF, GMCSF, GCSF, TGF, Erythropoetin, TPO, BMP, HGF, GDF, Neurotrophins, MSF, SGF, GDF and growth factors) moreover the microvesicles and exosomes released by this cells can prevent cells from apoptosis and stimulate regenerative process of surrounding tissues and cells.
SVF will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after cell injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.
| Arm | Type | Receives |
|---|---|---|
| Lipoaspiration and SVF introduction I. | Experimental | Biological: Lipoaspiration and SVF introduction., Drug: Standard therapy.Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction. |
| Standard therapy I. | Active comparator | Drug: Standard therapy.Patients with azoospermia that introduce with Standard therapy only. |
| Lipoaspiration and SVF introduction II | Experimental | Biological: Lipoaspiration and SVF introduction., Drug: Standard therapy.Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction. |
| Standard therapy II. | Active comparator | Drug: Standard therapy.Patients with oligospermia that introduce with Standard therapy only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- idiopathic oligozoospermia (spermatozoid number <2x10^6/mL) - 10 patients
- cryptozoospermia/azoospermia - 10 patients
Key exclusion criteria (16 listed)
- age before 18 or after 60 years old
- heart insufficiency. stroke (during 1 year)
- anemia
- blood disease
- pelvis bone trauma
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 |
|---|---|---|
| Lipoaspiration and SVF introduction.Lipoaspiration, isolation of SVF and introduction into testis Interstitium. | Biological | Lipoaspiration and SVF introduction I., Lipoaspiration and SVF introduction II |
| Standard therapy.Also: healthy diet, physical exertion eliminate. hormone therapy.Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed. | Drug | Lipoaspiration and SVF introduction I., Lipoaspiration and SVF introduction II, Standard therapy I., Standard therapy II. |
Primary outcome
sperm concentration in ejaculate
Time frame: 1, 2, 3 month
Sperm quantity and quality will be evaluated with automatic sperm cout analyzer a month, two and three after injection of SVF. Total measures - 3.
Spermatozoa in testicular biopsy
Time frame: 3 month
Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
3 secondary outcomes
Testosterone
Time frame: 3 month
Inhibin-B
Time frame: 3 month
Follicle stimulating hormone (FSH)
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Related trials for Azoospermia
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
RecruitingPhase 1/2
Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.
Non-obstructive Azoospermia
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
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. This study is not recruiting at the moment.
Olga Tyumina, M.D. P.h.D. study chair
Medical Centre Dinasty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipoaspiration and SVF introduction. and Standard therapy. in people with Azoospermia and Oligozoospermia, run by State-Financed Health Facility "Samara Regional Medical Center Dinasty" 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 2 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sperm concentration in ejaculate (time frame: 1, 2, 3 month). 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?
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 22 Oct 2020.