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

NCT03762967 | Unknown Phase 2 DMC

• 1 other identifier: 23032018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Azoospermia; Oligozoospermia

Keywords

Autologous Stem Cell; Male infertility; Adipose-Derived stem cell; Azoospermia; Oligospermia

Outcome Measures

Primary Outcomes (2)

• 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.

  1, 2, 3 month

• Spermatozoa in testicular biopsy

  Testicular sperm aspiration (TESA) will be performed after 3 month after SVF injection.

  3 month

Secondary Outcomes (3)

• Testosterone

  3 month

• Inhibin-B

  3 month

• Follicle stimulating hormone (FSH)

  3 month

Study Arms (4)

Lipoaspiration and SVF introduction I.

EXPERIMENTAL

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

Biological: Lipoaspiration and SVF introduction.; Drug: Standard therapy.

Standard therapy I.

ACTIVE COMPARATOR

Patients with azoospermia that introduce with Standard therapy only.

Drug: Standard therapy.

Lipoaspiration and SVF introduction II

EXPERIMENTAL

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

Biological: Lipoaspiration and SVF introduction.; Drug: Standard therapy.

Standard therapy II.

ACTIVE COMPARATOR

Patients with oligospermia that introduce with Standard therapy only.

Drug: Standard therapy.

Interventions

Lipoaspiration and SVF introduction. BIOLOGICAL

Lipoaspiration, isolation of SVF and introduction into testis Interstitium.

Lipoaspiration and SVF introduction I.; Lipoaspiration and SVF introduction II

Standard therapy. 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.

Also known as: healthy diet, physical exertion eliminate. hormone therapy.

Lipoaspiration and SVF introduction I.; Lipoaspiration and SVF introduction II; Standard therapy I.; Standard therapy II.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• idiopathic oligozoospermia (spermatozoid number \<2x10\^6/mL) - 10 patients
• cryptozoospermia/azoospermia - 10 patients

You may not qualify if:

• 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

Sponsors & Collaborators

• State-Financed Health Facility "Samara Regional Medical Center Dinasty": lead

Study Sites (1)

Medical Centre Dinasty

Samara, 443095, Russia

Location

MeSH Terms

Conditions

Azoospermia; Oligospermia; Infertility, Male

Interventions

Standard of Care; Diet, Healthy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Olga Tyumina, M.D. P.h.D.

  Medical Centre Dinasty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, Quality assurance director

Model Details: The study consist 40 patients in 4 groups. Two working groups and two control groups. Each group consist 10 Males.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 4, 2018
• Study Start: March 12, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

RU (1)