Frozen Embryo Donation Study

Infertility Clinical Trial

— FREDS  

Official title:

Increasing the Use of Donated Embryos: A Demonstration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883934
• Other study ID #: FREDS
• Secondary ID: EAAPA111016
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: February 3, 2016
• Start date: September 2011
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3568
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient at Boston IVF with embryos frozen in storage

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• Control

Locations

Country	Name	City	State
United States	Boston IVF	Waltham	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston IVF	Brandeis University, Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in embryo donation	We will be tracking to see if there is an increase in embryo donation as a result of the study	Approximately 2 years	No