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

NCT ID: NCT03762967

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2021-12-30

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.

Conditions

Azoospermia; Oligozoospermia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lipoaspiration and SVF introduction I.

Patients with azoospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.

Group Type: EXPERIMENTAL

Lipoaspiration and SVF introduction.

Intervention Type: BIOLOGICAL

Lipoaspiration, isolation of SVF and introduction into testis Interstitium.

Standard therapy.

Intervention Type: DRUG

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.

Standard therapy I.

Patients with azoospermia that introduce with Standard therapy only.

Group Type: ACTIVE_COMPARATOR

Standard therapy.

Intervention Type: DRUG

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.

Lipoaspiration and SVF introduction II

Patients with oligospermia that introduce with standard treatment and Lipoaspiration and SVF introduction.

Group Type: EXPERIMENTAL

Lipoaspiration and SVF introduction.

Intervention Type: BIOLOGICAL

Lipoaspiration, isolation of SVF and introduction into testis Interstitium.

Standard therapy.

Intervention Type: DRUG

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.

Standard therapy II.

Patients with oligospermia that introduce with Standard therapy only.

Group Type: ACTIVE_COMPARATOR

Standard therapy.

Intervention Type: DRUG

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.

Interventions

Lipoaspiration and SVF introduction.

Lipoaspiration, isolation of SVF and introduction into testis Interstitium.

Intervention Type: BIOLOGICAL

Standard 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.

Intervention Type: DRUG

Other Intervention Names

healthy diet, physical exertion eliminate. hormone therapy.

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….)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

State-Financed Health Facility "Samara Regional Medical Center Dinasty"

OTHER

Sponsor Role: lead

Responsible Party

Volchkov Stanislav

Deputy director, Quality assurance director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Tyumina, M.D. P.h.D.

Role: STUDY_CHAIR

Medical Centre Dinasty

Locations

Medical Centre Dinasty

Samara, , Russia

Countries

Russia

Other Identifiers

23032018

Identifier Type: -

Identifier Source: org_study_id