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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
Sponsor:
Collaborators:
Department of Health and Human Services
Brandeis University
Information provided by (Responsible Party):
Alison Zimon, Boston IVF

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.

Condition or disease Intervention/treatment Phase
Infertility Other: Enhanced clinic-based support/counseling Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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
Other: Control



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient at Boston IVF with embryos frozen in storage

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Boston IVF
Department of Health and Human Services
Brandeis University
Investigators
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Principal Investigator: Alison Zimon, MD Boston IVF
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alison Zimon, Reproductive Endocrinologist, Boston IVF
ClinicalTrials.gov Identifier: NCT01883934    
Other Study ID Numbers: FREDS
EAAPA111016 ( Other Grant/Funding Number: Department of Health and Human Services )
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Alison Zimon, Boston IVF:
In Vitro Fertilization (IVF)
Embryo donation
Additional relevant MeSH terms:
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Infertility