Azoospermia, Oligozoospermia
Conditions
Keywords
Autologous Stem Cell, Male infertility, Adipose-Derived stem cell, Azoospermia, Oligospermia
Brief 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. 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.
Interventions
BIOLOGICALLipoaspiration and SVF introduction.
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.
Sponsors
State-Financed Health Facility Samara Regional Medical Center Dinasty
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* idiopathic oligozoospermia (spermatozoid number \<2x10\^6/mL) - 10 patients * cryptozoospermia/azoospermia - 10 patients
Exclusion criteria
* 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 * 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….)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sperm concentration in ejaculate | 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 | 3 month | Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone | 3 month | Testosterone will be measured a three month after injection of SVF. |
| Inhibin-B | 3 month | Inhibin-B will be measured a three month after injection of SVF. |
| Follicle stimulating hormone (FSH) | 3 month | Follicle stimulating hormone will be measured a three month after injection of SVF. |
Countries
Russia
Outcome results
None listed