Clinical trial NCT03762967: Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility
Official title: Efficiency Evaluation of Adipose-Derived Adult Stromal Vascular Cells in Patients With Spermatogenesis Disorders.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Azoospermia
Oligozoospermia
Keywords: Autologous Stem Cell
Male infertility
Adipose-Derived stem cell
Azoospermia
Oligospermia
Lead sponsor: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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....)

Primary outcomes:
measure: sperm concentration in ejaculate
timeFrame: 1, 2, 3 month
measure: Spermatozoa in testicular biopsy
timeFrame: 3 month
Secondary outcomes:
measure: Testosterone
timeFrame: 3 month
measure: Inhibin-B
timeFrame: 3 month
measure: Follicle stimulating hormone (FSH)
timeFrame: 3 month
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Medical Centre Dinasty
Study officials:
affiliation: Medical Centre Dinasty
name: Olga Tyumina, M.D. P.h.D.
role: STUDY_CHAIR
References: