NCT01375062

Brief Summary

The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 19, 2015

Status Verified

March 1, 2014

Enrollment Period

2.2 years

First QC Date

June 7, 2011

Last Update Submit

October 16, 2015

Conditions

Azoospermia

Outcome Measures

Primary Outcomes (1)

  • Assessment of potential germinal and pluripotent of the isolated cultures.

    •The spermatogonial cells isolated from testicular biopsies of azoospermic patients will be matured in vitro for thegeneration of sperm for infertility treatment. \* Undifferentiated cells of the testis biopsy will be characterized as degrees of plasticity for proof that they are capable of regeneration spermatogenesis.

    one month

Study Arms (1)

tissue from biopsies

NO INTERVENTION
Other: analyse and proliferate the cells

Interventions

analyse and proliferate the cellsOTHER

1. Obtention of excess tissue from testicular biopsies and maintained in 4ºC until procedures. 2. Digestion of the biopsies through controlled enzymes 3. Replication of the cells 4. Selection undifferentiated cells 5. Expansion of the purification cells population 6. Characterization of the cell population 7. Assessment of pluripotent and germinal cell potential. 8. Possible maturation of the cells.

tissue from biopsies

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • azoospermic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Azoospermia

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Carlos Simon, MDPhD

    IVI Valencia

    STUDY DIRECTOR

  • Marcia Riboldi, PhD

    Fundación IVI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Gynecologist IVI Valencia

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 17, 2011

Study Start

May 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 19, 2015

Record last verified: 2014-03

Locations

ES(1)