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Frozen Embryo Donation Study (FREDS)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced clinic-based support/counseling
Control
Sponsored by
Boston IVF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infertility focused on measuring In Vitro Fertilization (IVF), Embryo donation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient at Boston IVF with embryos frozen in storage

Sites / Locations

  • Boston IVF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced clinic-based support/counseling

Patients receiving standard of care

Arm Description

Scheduling a consult with a licensed social worker to discuss embryo disposition options. Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered.

Patients who receive standard of care regarding embryo disposition options

Outcomes

Primary Outcome Measures

Increase in embryo donation
We will be tracking to see if there is an increase in embryo donation as a result of the study

Secondary Outcome Measures

Full Information

First Posted
May 21, 2013
Last Updated
February 3, 2016
Sponsor
Boston IVF
Collaborators
Department of Health and Human Services, Brandeis University
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1. Study Identification

Unique Protocol Identification Number
NCT01883934
Brief Title
Frozen Embryo Donation Study
Acronym
FREDS
Official Title
Increasing the Use of Donated Embryos: A Demonstration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston IVF
Collaborators
Department of Health and Human Services, Brandeis University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to improve patient understanding of and interest in donating frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility treatment.
Detailed Description
The first phase of this study involves the mailing of a survey to current Boston IVF patients who have embryos frozen in storage. A survey will be sent to these individuals to assess their knowledge and understanding of frozen embryos and if they would be interested in embryo donation. The second phase of research will randomize these patients into two groups: control and intervention. The control groups will receive their standard of treatment regarding frozen embryos, which consists of receiving a yearly storage bill. The intervention group will receive a letter from their physician of record and a follow up phone call from a research assistant offering the opportunity to schedule a consult with a licensed social worker at Boston IVF. The consult is meant to serve as a chance to discuss the difficult decision around embryo disposition. The consult for these patient will be free of charge, covered with funds from our grant. Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered. These enhanced services will also be free of charge to subjects. The third phase of the study includes the mailing of a letter to a random sample of patients with embryos frozen in storage at Boston IVF. This letter will be an invitation to contact Boston IVF to schedule a consult with a licensed social worker to discuss embryo disposition options. The consult for these patient will be free of charge, covered with funds from our grant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In Vitro Fertilization (IVF), Embryo donation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced clinic-based support/counseling
Arm Type
Experimental
Arm Description
Scheduling a consult with a licensed social worker to discuss embryo disposition options. Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered.
Arm Title
Patients receiving standard of care
Arm Type
Active Comparator
Arm Description
Patients who receive standard of care regarding embryo disposition options
Intervention Type
Other
Intervention Name(s)
Enhanced clinic-based support/counseling
Intervention Description
Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered.
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Increase in embryo donation
Description
We will be tracking to see if there is an increase in embryo donation as a result of the study
Time Frame
Approximately 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient at Boston IVF with embryos frozen in storage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Zimon, MD
Organizational Affiliation
Boston IVF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31415660
Citation
Zimon AE, Shepard DS, Prottas J, Rooney KL, Ungerleider J, Halasa-Rappel YA, Sakkas D, Oskowitz SP. Embryo donation: Survey of in-vitro fertilization (IVF) patients and randomized trial of complimentary counseling. PLoS One. 2019 Aug 15;14(8):e0221149. doi: 10.1371/journal.pone.0221149. eCollection 2019.
Results Reference
derived

Learn more about this trial

Frozen Embryo Donation Study

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