Can Pregnancy be Predicted According to ATR-FTIR Spectrop... | NCT03317418

Studies
Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF

NCT03317418

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jun 23, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Infertility

Interventions

ATR-FTIR Spectrophotometry

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Nov 2023Estimated

First Submitted Date

Oct 18, 2017

First Submission Date that Met QC Criteria

Oct 18, 2017

First Posted Date

Oct 23, 2017Actual

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

Jun 22, 2022

Last Update Posted Date

Jun 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this study is to examine the variability of culture media composition based on the ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on the day of embryo transfer/vitrification. In addition, the study will explore whether variations detected in the culture medium can be linked to embryo quality and the chances of achieving pregnancy.

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

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

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
ATR-FTIR Spectrophotometry	Other	Spectrometry imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spectrometry in embryo culture media	Definition of spectrometry in embryo culture media	One year
Embryo quality	The spectrometry results will be linked to embryo quality through the linkage between spectrometry results as indicated on Absorbance Graph and embryo quality judged by accepted criteria	One year

Secondary Outcomes

Measure	Description	Time Frame
Cycle outcomes	Prediction of pregnancy rates as linked to the spectrometry results of the culture media	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women undergoing IVF treatments with at least 4 embryos

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women attending the fertility clinic at Hillel Yaffe Medical Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nardin Aslih, MD	Contact	972-54-4843909		nardin_aslih@yahoo.com

Overall Officials

Name	Affiliation	Role
Einat Shalom Paz, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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