Stem cell transplantation in human testis for the treatment of male infertility
| ISRCTN | ISRCTN75604065 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75604065 |
| Secondary identifying numbers | 1 |
- Submission date
- 05/01/2009
- Registration date
- 27/02/2009
- Last edited
- 27/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Zaid Kilani
Scientific
Scientific
The Farah Hospital
May Ziadeh Street
P.O. Box 5323
Jabal
4th circle
Amman
11183
Jordan
| Phone | +962 6 460 3555 |
|---|---|
| farah1@go.com.jo |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Bone marrow stem cell transplantation in human testis for men with sever oligospermia or azospermia: a pilot study |
| Study hypothesis | Testes have two main functions in mammals: to produce androgens and spermatogenesis which occurs in the seminiferous tubules. Spermatogonial stem cells are undifferentiated cells defined by their ability to both self-renew and differentiate into mature spermatozoa. Bone marrow stem cells (BMS cells) have been shown to be able to transdifferentiate to male germ cell-like cells. In male mice, a recent study has demonstrated that bone marrow stem cells are able to differentiate into primordial germ cells and spermatogonia both in vitro and in vivo. In a more recent study, adult bone marrow cells injected into seminiferous tubules or interstitial spaces were not only able to differentiate into germ cells (spermatogonia and spermatocytes) but as well as Sertoli and Leydig cells. This finding may be of clinical relevance to unique treatment of male infertility. The ability to derive male germ cells from BMS cells opens the possibilities for use of these cells in reproductive medicine mainly male infertility. In order to encourage BMS cells to differentiate into germ cells, the isolated cells should be cultured in a medium very similar to that found in the testes. Thus, Obtaining BMS cells from the infertile man and injecting it - after preparation - into the seminefrous tubules or around it may stimulate its differentiation into germ cells. |
| Ethics approval(s) | The Farah Hospital Ethical Committee, approved on 13/12/2008 (ref: 1). |
| Condition | Male infertility and spermatogenesis |
| Intervention | 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 oligospermia group, 20 cases will receive BMS cells and in the azospermia group, only 10 will receive it. Randomisation ratio will be 1:1. For safety of participants, BMS cells will be injected in one testis only and the other testis will be spared. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 15/01/2009 |
| Overall study end date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 60 |
| Participant 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 |
| Participant exclusion criteria | 1. Men with previous surgery in testis 2. Those with major medical problem such as malignancy, hepatitis, etc. |
| Recruitment start date | 15/01/2009 |
| Recruitment end date | 01/06/2010 |
Locations
Countries of recruitment
- Jordan
Study participating centre
The Farah Hospital
Amman
11183
Jordan
11183
Jordan
Sponsor information
The Farah Hospital (Jordan)
Hospital/treatment centre
Hospital/treatment centre
May Ziadeh Street
P.O. Box 5323
Jabal
4th circle
Amman
11183
Jordan
| Phone | +962 6 460 3555 |
|---|---|
| farah1@go.com.jo | |
| Website | http://www.farah-hospital.org/ |
"ROR" |
https://ror.org/02qnzpb65 |
Funders
Funder type
Hospital/treatment centre
The Farah Hospital (Jordan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
