Discarded Materials Study | NCT01219335

Studies
Discarded Materials Study

NCT01219335

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Recruiting

Last Update Posted

Jun 3, 2026Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

United States

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 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Oct 8, 2010

First Submission Date that Met QC Criteria

Oct 8, 2010

First Posted Date

Oct 13, 2010Estimated

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 1, 2026

Last Update Posted Date

Jun 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Use of discarded embryos to advance laboratory expertise and technology in the area of human embryo development and assisted reproductive technologies

Detailed Description

1- Testing methods or freezing before implementing techniques. 2- Develop cell surgery and micromanipulation techniques. 3- Develop methods to optimize the determinations of genes and chromosomes 4- Quality-assess laboratory equipment. 5- Test proficiency of laboratory staff. 6- Analyze what effects the early development of embryos. 7- Develop new methods and media to allow for higher survival rates of embryos. 8- Develop non-invasive tests for predicting embryo quality to predict IVF success.

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

Retention

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Methods for freezing -embryos	To test, standardize and implement better methods for the freezing embryos prior to these techniques being used in the clinical setting	duration of the study

Secondary Outcomes

Measure	Description	Time Frame
Development non-invasive tests	To develop non-invasive tests for predicting embryo quality as well as IVF success	duration of the study
Factors that control embryo development	To analyze embryos to learn more about what controls their early development and function.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

none

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing infertility treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christine V Whitehead, BSN, RN	Contact	973-656-2841		clinicalresearchteam@rmanj.com
Caroline Zuckerman, RN	Contact	973-656-2841		clinicalresearchteam@rmanj.com

Overall Officials

Name	Affiliation	Role
Thomas Molinaro, MD, MSCE	Reproductive Medicine Associates of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medicine Associates of new Jersey	Recruiting	Basking Ridge	New Jersey	07920	United States

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