Study of Ovum Donors After Donation | NCT01219374

Studies
Study of Ovum Donors After Donation

NCT01219374

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Completed

Last Update Posted

Jan 24, 2013Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Anonymous Donors

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

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

Jan 22, 2013

Last Update Posted Date

Jan 24, 2013Estimated

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

To explore the attitudes and reactions of ovum donors prospectively after ovum donation and to follow their medical histories.

Detailed Description

Although several studies have explored donor's reactions and experiences up to a year post donation, no study has explored how donor attitudes and reactions change over time. Currently, there is no long-term data available to describe donor's feelings and reactions to their donation. Consequently, programs have no guidance to counsel prospective donors about whether donors' attitudes change towards their own participation, contact with any offspring, or concerns about the donation. In addition, just as ovum donors' initial health histories were shared anonymously with the recipient(s), any updated information gathered in this study would be shared anonymously with the recipient(s) or offspring should they request those updates.

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

500Actual

Label	Type	Description	Intervention Names
egg donors		anonymous egg donors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Do recipients' attitudes and reactions change over time regarding the selection criteria for their donors?	Analysis of recipients' attitudes and reactions at initial psychoeducational consultation, a week after the initial psychoeducational consultion, at donor match and 3 months after delivery	12-15 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

All anonymous egg donors are eligible for participation.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Anonymous egg donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea M Braverman, PhD	Reproductive Medicine Associates of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medicine Associates of New Jersey		Morristown	New Jersey	07690	United States