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临床试验/IRCT20190519043634N1
IRCT20190519043634N1尚未招募1 期

Intra-testicular Injection of Autologous Adipose Derived Mesenchymal Stem Cell (ADMSC) in Non-obstructive Azoospermia Patients: Clinical Trial, Phase I, Non-Randomized

ational Center of Science and Technology Evaluation0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20 years 至 50 years(—)
性别
Male

入选标准

  • 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.

排除标准

  • 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

研究者

发起方
ational Center of Science and Technology Evaluation

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