Frozen Embryo Donation Study (FREDS)

Boston IVF

Status: Completed

Conditions: Infertility

Treatments: Other: Control; Other: Enhanced clinic-based support/counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01883934

FREDS

EAAPA111016 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,568 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient at Boston IVF with embryos frozen in storage

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,568 participants in 2 patient groups

Enhanced clinic-based support/counseling

Experimental group

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.

Treatment:

Other: Enhanced clinic-based support/counseling

Patients receiving standard of care

Active Comparator group

Description:

Patients who receive standard of care regarding embryo disposition options

Treatment:

Other: Control