Male infertility and spermatogenesis Urological and Genital Diseases Male infertility
Conditions
Interventions
Forty men with sever oligospermia and 20 men with azospermia will be recruited (total: 60 participants).
Participants will be randomised to have BMS cells transplantation or no therapy. In the oligos
Sponsors
The Farah Hospital (Jordan)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men with idiopathic severe oligospermia defined as less than one million sperm per ml, or men with azospermia 2. Men between 20-50 years old 3. Normal serum levels of gonadotropines, testosterone and prolactine 4. Absence of infectious genital disease and anatomical abnormalities of the genital tract 5. Absence of smoking, drug addiction or alcohol consumption
Exclusion criteria
Exclusion criteria: 1. Men with previous surgery in testis 2. Those with major medical problem such as malignancy, hepatitis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Laboratory safety: White Cell Count (WCC) and platelet count, assessed once per month for three month 2. In azospermia group: Histopathology of evidence of differentiation. Testicular biopsy will be obtained after three month of injection. 3. In oligospermia group: Significant increase in number of sperms on three successive semen samples, assessed after 1, 2 and 3 months of injection All primary outcome measures will be followed up for 180 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sperm activity and ability to fertilise oocyte, assessed each time sperm is obtained throughout the study 2. Pregnancy rate within one year of injection 3. Miscarriage rate within one year of injection 4. Long term follow-up for any adverse effect, assessed for one year from injection All secondary outcome measures will be followed-up for one year. | — |
Countries
Jordan
Outcome results
None listed