Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3568 participants
INTERVENTIONAL
2011-09-30
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
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.
Patients receiving standard of care
Patients who receive standard of care regarding embryo disposition options
Control
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
Brandeis University
OTHER
Boston IVF
OTHER
Responsible Party
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Alison Zimon
Reproductive Endocrinologist
Principal Investigators
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Alison Zimon, MD
Role: PRINCIPAL_INVESTIGATOR
Boston IVF
Locations
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Boston IVF
Waltham, Massachusetts, United States
Countries
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References
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Zimon AE, Shepard DS, Prottas J, Rooney KL, Ungerleider J, Halasa-Rappel YA, Sakkas D, Oskowitz SP. Embryo donation: Survey of in-vitro fertilization (IVF) patients and randomized trial of complimentary counseling. PLoS One. 2019 Aug 15;14(8):e0221149. doi: 10.1371/journal.pone.0221149. eCollection 2019.
Other Identifiers
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EAAPA111016
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FREDS
Identifier Type: -
Identifier Source: org_study_id
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