NCT01883934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

May 21, 2013

Last Update Submit

February 3, 2016

Conditions

Infertility

Keywords

In Vitro Fertilization (IVF)Embryo donation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Enhanced clinic-based support/counseling

EXPERIMENTAL

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.

Other: Enhanced clinic-based support/counseling

Patients receiving standard of care

ACTIVE COMPARATOR

Patients who receive standard of care regarding embryo disposition options

Other: Control

Interventions

Enhanced clinic-based support/counselingOTHER

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
ControlOTHER
Patients receiving standard of care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at Boston IVF with embryos frozen in storage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

  • 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.

    PMID: 31415660DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Counseling

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Alison Zimon, MD

    Boston IVF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reproductive Endocrinologist

Study Record Dates

First Submitted

May 21, 2013

First Posted

June 21, 2013

Study Start

September 1, 2011

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

US(1)