NCT01501292

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

December 13, 2011

Last Update Submit

December 26, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation

    Identification the different patterns of mitochondrial distribution in correlation with the 3 stages nuclear maturation in human oocytes

    Three months

Study Arms (2)

Immature oocytes (GV, M-I)

Other: Fixation and stainingOther: Observation by laser microscopy

Mature oocytes (M-II)

Other: Fixation and stainingOther: Observation by laser microscopy

Interventions

Fixation and staining by MitiTracker Green FM

Immature oocytes (GV, M-I)Mature oocytes (M-II)

Observation with Laser scanning confocal microscopy

Immature oocytes (GV, M-I)Mature oocytes (M-II)

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing routine in-vitro fertilization with ICSI

You may qualify if:

  • Infertile patients needing IVF treatment

You may not qualify if:

  • Patients not requiring the ICSI procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

Staining and Labeling

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative Techniques

Central Study Contacts

Adrian Ellenbogen, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 29, 2011

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations