Changes in the Distribution of Mitochondria During Oocyte... | NCT01501292

Studies
Changes in the Distribution of Mitochondria During Oocyte Maturation

NCT01501292

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Dec 29, 2011Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Fixation and staining
Observation by laser microscopy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Apr 2012Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 26, 2011

First Posted Date

Dec 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2011

Last Update Posted Date

Dec 29, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immature oocytes (GV, M-I)			Other: Fixation and staining Other: Observation by laser microscopy
Mature oocytes (M-II)			Other: Fixation and staining Other: Observation by laser microscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fixation and staining	Other	Fixation and staining by MitiTracker Green FM	Immature oocytes (GV, M-I) Mature oocytes (M-II)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infertile patients needing IVF treatment

Exclusion Criteria:

Patients not requiring the ICSI procedure

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Patients undergoing routine in-vitro fertilization with ICSI

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adrian Ellenbogen, MD	Contact	972-50-6246722		ellenbogen@hy.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013194	Staining and Labeling

Ancestor Terms

ID	Term
D016591	Histocytological Preparation Techniques
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided