Frozen Embryo Donation Study

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Enhanced clinic-based support/counseling; Other: Control

• Registration Number: NCT01883934
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Primary Completion: 2014-08
• Study Completion: 2014-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3568

Inclusion Criteria

• Patient at Boston IVF with embryos frozen in storage

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced clinic-based support/counseling	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.
Patients receiving standard of care	Control	Patients who receive standard of care regarding embryo disposition options

Primary Outcome Measures

Name	Time	Method
Increase in embryo donation	Approximately 2 years	We will be tracking to see if there is an increase in embryo donation as a result of the study

Trial Locations

Locations (1)

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States