InfertilityNCT00544089
Chromosomal and Morphological Structure of Mature and Immature Male Germ Cells and Recognition of IL-18 in Testicular Tissue of Azoospermic Men
An observational study of Infertility, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
To develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients). Read more about this study
- Who is it for?
- Ages 22 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 25,907 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-obstructive azoospermic patients
Who cannot join
- Obstructive azoospermia
Trial locations and contacts
1 site in 1 country.
About this study
To develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients).
To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it has been suggested that this cytokine may serve as a paracrine defense factor in the male gonad associated to spermatogenesis.
Read the detailed description
A new biotechnological assay was developed by adapting an existing computerized system which scans cell morphology and chromosomal ploidy in the same cell of hematologic line using digital technology, to recognize germ cells of the testis by their morphology and cytogenetics. Testicular tissues which obtained from 15 men were enzymatically digested and the cells received were fixed on slides. The cells were stained by Giemsa May Grinwald staining and scanned automatically in a bright field for cell morphology. Fluorescence in situ hybridization (FISH) using centromeric probes for chromosomes X, Y and 18 was performed on the same slide after destaining. The cells were automatically scanned and classified according to the ploidy of the chromosome signals. The presence of IL-18 in the same men's testis was examined parallelly, by immunohistochimical staining using specific antibody for human IL-18.
- Conditions
- Infertility
- Keywords
- azoospermia FISH IL-18 TESTICULAR BIOPSY
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startMar 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 25,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Raphael Ron-el, professor, Principal investigator, Assaf-Harofeh Medical Canter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544089
- Sponsor's protocol ID
- 37/06
- Status last verified
- Mar 2006
- First submitted
- 14 Oct 2007
- Last updated
- 16 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromosomal and Morphological Structure of Mature and Immature Male Germ Cells and Recognition of IL-18 in Testicular Tissue of Azoospermic Men
- ClinicalTrials.gov ID
- NCT00544089
- Acronym / sponsor ID
- 37/06
- Conditions
- Infertility
- Keywords
- azoospermia FISH IL-18 TESTICULAR BIOPSY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,907 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients).
To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it has been suggested that this cytokine may serve as a paracrine defense factor in the male gonad associated to spermatogenesis.
Detailed description
A new biotechnological assay was developed by adapting an existing computerized system which scans cell morphology and chromosomal ploidy in the same cell of hematologic line using digital technology, to recognize germ cells of the testis by their morphology and cytogenetics. Testicular tissues which obtained from 15 men were enzymatically digested and the cells received were fixed on slides. The cells were stained by Giemsa May Grinwald staining and scanned automatically in a bright field for cell morphology. Fluorescence in situ hybridization (FISH) using centromeric probes for chromosomes X, Y and 18 was performed on the same slide after destaining. The cells were automatically scanned and classified according to the ploidy of the chromosome signals. The presence of IL-18 in the same men's testis was examined parallelly, by immunohistochimical staining using specific antibody for human IL-18.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-obstructive azoospermic patients
Key exclusion criteria (1 listed)
- Obstructive azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Ron-el, professor principal investigator
Assaf-Harofeh Medical Canter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2007.