Modulation Contrast Microscopy Imaging for Oocyte Quality... | NCT03683290

Studies
Modulation Contrast Microscopy Imaging for Oocyte Quality Assessment

NCT03683290

Sponsor

Center for Reproductive an Genetic Health

Status

Unknown status

Last Update Posted

Sep 9, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Oocyte Competence

Interventions

Image acquisition and analysis

Countries

United Kingdom

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Aug 10, 2020Actual

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Sep 18, 2018

First Submission Date that Met QC Criteria

Sep 21, 2018

First Posted Date

Sep 25, 2018Actual

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

Sep 7, 2020

Last Update Posted Date

Sep 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xavier Vinals Gonzalez, Principal investigator, Center for Reproductive an Genetic HealthPrincipal Investigator

Lead Sponsor

Center for Reproductive an Genetic HealthINDUSTRY

Collaborators

Name	Class
University College, London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The present study aims to describe novel non-invasive parameters related to the competence of female reproductive cells (oocytes). In a fertility unit, human reproductive cells and embryos are subjected to different imaging technologies. Images can easily be obtained without disturbing the microenvironment during different standard procedures. Turning images into quantifiable data might provide a further understanding on oocyte behavior and performance in the laboratory.

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

Yes

Target Follow-Up Duration

40 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Image acquisition and analysis	Other	Oocyte image obtention and analysis prior to intracytoplasmic sperm injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implantation	Number of gestational sacs seen on ultrasound scan	6 weeks gestation

Secondary Outcomes

Measure	Description	Time Frame
Live Birth	Baby to be born after embryo transfer	40 weeks gestation
Fertilisation	Appearance of two pronucleii after insemination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intracytoplasmic sperm injection
Embryo culture with subsequent fresh embryo transfer

Exclusion Criteria:

- Conventional IVF

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Registered patients at The Centre for Reproductive and Genetic Health

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sioban SenGupta	Institute for Women's Health (UCL)	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Reproductive and Genetics Health		London		W1W 5QS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be collected and analysed internally. Results will be available (if published) in a scientific journal.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided