Azoospermia Treatment with Mesenchymal Stem Cell

Phase 1

Not yet recruiting

• Conditions: on-obstructive Azoospermia.

• Registration Number: IRCT20190519043634N1
• Lead Sponsor: ational Center of Science and Technology Evaluation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

20-50 years infertile males seeking fertility treatment with confirmed diagnosis of Non-obstructive azoospermia (NOA).
Patients with confirmed diagnostic of Non-obstructive azoospermia based on 2 negative spermogram with centrifugation (three months in between).
Patients without sperm cells at semen analysis.
Body mass index (BMI) lower than 35.
Negative testicular sperm extraction (TESE): Failure of detecting spermatozoid TESE.

Exclusion Criteria

Treated with drug which could improve sperm count and quality one month before observation, otherwise, they should have an elution for 1 month before the study.
Previous surgical history in Testis. Absent or surgical removed testes
Infectious genital diseases. Gram-positive bacteria, Chlamydia Trachomatis,Ureaplasma Urealyticum, or Mycoplasma Hominis were detected in their semen.
Anatomical abnormalities of the genital tract
Patients with grade 2 or 3 varicocele, persistent after cure of the varicocele.
Current or history of testicular tumor detected or testicular cancer or history of any other cancer.
Obstructive azoospermia (FSH <7.6 IU/mL plus testicle longitudinally axis >4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy).
Hypogonadotropic hypogonadism (LH <2 IU/mL and Follicle Stimulating Hormone (FSH) <1 IU/mL).
Patient with Klinefelter or karyotype abnormalities
Seminal white blood cell concentration more than 10 million per ml
Use of chemotherapy, testosterone, or anti-androgen in the last two years.
Partner >40 years or female factor infertility associated.
Addicted to drug, tobacco, or alcohol.
Under treatment of gonadotropin, anabolic steroid, chemotherapeutic drugs, or nonsteroidal anti-inflammatory drugs.
Combined with cardiovascular, liver, kidney, or hematopoietic system severe primary disease, or mental disease.
Had heat, chemicals, radioactive material, or toxic contact history within a year.
Presence of genetic disorders: abnormal karyotypes and Chromosomal aberration (e.g. Y microdeletion, trisomy….
First TESE conducted under hormonal treatment (Clomifene, Tamoxifen, gonadotrophins or anti-aromatase)
Receiving a treatment known to alter male fertility (see RCP of the treatment, colchicine, methotrexate and…) in the 6 months before inclusion.
Receiving treatment know to modify the gonadotroph axis activity (FSH, TESTO, DHT, HCG…)
Persistent bilateral abdominal cryptorchidism or history of cryptorchidism
Patient unable to understand the purpose of the trial or refusing to follow treatment and post-treatment instructions
Participation to another trial that would interfere with this trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induction of spermatogenesis. Timepoint: at 2 week, 1, 2, 3, 4, 5 and 6 post injection day. Method of measurement: Hematological, biochemical, Retrieval sperm rate ,Sperm density, Sperm motility, Total serum testosterone level (TH), Number spermatogonia, Number of spermatocytes, Total serum estradiol level, Total serum follicle stimulating hormone level (FSH), Total serum luteinizing hormone level (LH), Inhibin B hormone, Prolactin, sexual function.