Frozen Embryo Donation Study (FREDS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01883934|
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: Enhanced clinic-based support/counseling Other: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3568 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Increasing the Use of Donated Embryos: A Demonstration|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||November 2014|
Experimental: Enhanced clinic-based support/counseling
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.
Other: Enhanced clinic-based support/counseling
Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered.
Active Comparator: Patients receiving standard of care
Patients who receive standard of care regarding embryo disposition options
- Increase in embryo donation [ Time Frame: Approximately 2 years ]We will be tracking to see if there is an increase in embryo donation as a result of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883934
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Principal Investigator:||Alison Zimon, MD||Boston IVF|