Condition category
Urological and Genital Diseases
Date applied
05/01/2009
Date assigned
27/02/2009
Last edited
27/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zaid Kilani

ORCID ID

Contact details

The Farah Hospital
May Ziadeh Street
P.O. Box 5323
Jabal
4th circle
Amman
11183
Jordan
+962 6 460 3555
farah1@go.com.jo

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Bone marrow stem cell transplantation in human testis for men with sever oligospermia or azospermia: a pilot study

Acronym

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

The Farah Hospital Ethical Committee, approved on 13/12/2008 (ref: 1).

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/01/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

60

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

Trial participating centre

The Farah Hospital
Amman
11183
Jordan

Sponsor information

Organisation

The Farah Hospital (Jordan)

Sponsor details

May Ziadeh Street
P.O. Box 5323
Jabal
4th circle
Amman
11183
Jordan
+962 6 460 3555
farah1@go.com.jo

Sponsor type

Hospital/treatment centre

Website

http://www.farah-hospital.org/

Funders

Funder type

Hospital/treatment centre

Funder name

The Farah Hospital (Jordan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes