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Completed

NCT Number: NCT01883934

Frozen Embryo Donation Study

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston IVF

Waltham, Massachusetts, 02451, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient at Boston IVF with embryos frozen in storage

Treatment and study plan

Enhanced clinic-based support/counseling

Other

Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered.

Control

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston IVF

Other

Collaborators

  • Brandeis University
  • Department of Health and Human Services

Registry information

Official study title

Increasing the Use of Donated Embryos: A Demonstration

Acronym: FREDS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2013
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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