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Changes in the Distribution of Mitochondria During Oocyte Maturation

This study is not yet open for participant recruitment.
Verified December 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01501292
First received: December 13, 2011
Last updated: December 26, 2011
Last verified: December 2011
History of Changes
  Purpose

Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. The aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent ICSI but did not become fertilized and are discarded.


Condition Intervention
Infertility
 Other: Fixation and staining
Other: Observation by laser microscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Identification the different patterns of mitochondrial distribution in correlation with the 3 stages nuclear maturation in human oocytes


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Immature oocytes (GV, M-I) Other: Fixation and staining
Fixation and staining by MitiTracker Green FM
Other: Observation by laser microscopy
Observation with Laser scanning confocal microscopy
Mature oocytes (M-II) Other: Fixation and staining
Fixation and staining by MitiTracker Green FM
Other: Observation by laser microscopy
Observation with Laser scanning confocal microscopy

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing routine in-vitro fertilization with ICSI

Criteria

Inclusion Criteria:

  • Infertile patients needing IVF treatment

Exclusion Criteria:

  • Patients not requiring the ICSI procedure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501292

Contacts
Contact: Adrian Ellenbogen, MD 972-50-6246722 ellenbogen@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Adrian Ellenbogen, MD            
Sub-Investigator: Ofer Fainaru, MD, PhD            
Sub-Investigator: Tal Shavit, MD            
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01501292     History of Changes
Other Study ID Numbers: 0095-11-HYMC
Study First Received: December 13, 2011
Last Updated: December 26, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013