A Phase 2 interventional study of Lipoaspiration and SVF introduction. and Standard therapy. in Azoospermia and Oligozoospermia, sponsored by State-Financed Health Facility "Samara Regional Medical Center Dinasty". Status unknown at 1 site in Russian Federation. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by State-Financed Health Facility "Samara Regional Medical Center Dinasty" · Phase 2, Interventional, and Treatment
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.
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.
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's planned enrollment of 40 is below the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →State-Financed Health Facility "Samara Regional Medical Center Dinasty" is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
Biological: Lipoaspiration and SVF introduction. · Drug: Standard therapy.
Patients with azoospermia that introduce with Standard therapy only.
Drug: Standard therapy.
Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
Biological: Lipoaspiration and SVF introduction. · Drug: Standard therapy.
Patients with oligospermia that introduce with Standard therapy only.
Drug: Standard therapy.
Lipoaspiration, isolation of SVF and introduction into testis Interstitium.
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.
Also known as: healthy diet, physical exertion eliminate. hormone therapy.
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.
Time frame: 1, 2, 3 month
Spermatozoa in testicular biopsy
Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
Time frame: 3 month
Testosterone
Testosterone will be measured a three month after injection of SVF.
Time frame: 3 month
Inhibin-B
Inhibin-B will be measured a three month after injection of SVF.
Time frame: 3 month
Follicle stimulating hormone (FSH)
Follicle stimulating hormone will be measured a three month after injection of SVF.
Time frame: 3 month
Started Mar 2018 (actual). Primary completion is estimated for Dec 2020, 33 months after the start.
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This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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State-Financed Health Facility "Samara Regional Medical Center Dinasty"