Autologous Adipose-Derived Adult Stromal Vascular Cell Administration for Male Patients With Infertility

Phase 2

• Conditions: Azoospermia; Oligozoospermia
• Interventions: Biological: Lipoaspiration and SVF introduction.; Drug: Standard therapy.

• Registration Number: NCT03762967
• Lead Sponsor: State-Financed Health Facility "Samara Regional Medical Center Dinasty"

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.

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2020-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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....)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipoaspiration and SVF introduction I.	Standard therapy.	Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
Lipoaspiration and SVF introduction II	Lipoaspiration and SVF introduction.	Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
Lipoaspiration and SVF introduction II	Standard therapy.	Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
Standard therapy I.	Standard therapy.	Patients with azoospermia that introduce with Standard therapy only.
Lipoaspiration and SVF introduction I.	Lipoaspiration and SVF introduction.	Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.
Standard therapy II.	Standard therapy.	Patients with oligospermia that introduce with Standard therapy only.

Primary Outcome Measures

Name	Time	Method
Spermatozoa in testicular biopsy	3 month	Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.
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.

Secondary Outcome Measures

Name	Time	Method
Testosterone	3 month	Testosterone 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.
Inhibin-B	3 month	Inhibin-B will be measured a three month after injection of SVF.

Trial Locations

Locations (1)

Medical Centre Dinasty; 🇷🇺 Samara, Russian Federation