InfertilityFREDSNCT01883934
Frozen Embryo Donation Study
A study testing Enhanced clinic-based support/counseling in people with Infertility, run by Boston IVF at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Enhanced clinic-based support/counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,568 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient at Boston IVF with embryos frozen in storage
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing the Use of Donated Embryos: A Demonstration
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Enhanced clinic-based support/counseling, Control
- Keywords
- In Vitro Fertilization (IVF), Embryo donation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Enhanced clinic-based support/counseling |
| Patients receiving standard of care | Active comparator | Patients who receive standard of care regarding embryo disposition options Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in embryo donation
We will be tracking to see if there is an increase in embryo donation as a result of the study
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Brandeis University
- Responsible party
- Principal investigator, Alison Zimon, Boston IVF
- Investigators
- Alison Zimon, MD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883934
- Sponsor's protocol ID
- FREDS
- Other IDs
- EAAPA111016
- Acronym
- FREDS
- Status last verified
- Feb 2016
- First submitted
- 21 May 2013
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31415660
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Use of Donated Embryos: A Demonstration
- ClinicalTrials.gov ID
- NCT01883934
- Acronym / sponsor ID
- FREDS / FREDS
- Conditions
- Infertility
- Keywords
- In Vitro Fertilization (IVF), Embryo donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,568 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Brandeis University
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced clinic-based support/counseling | Experimental | Other: Enhanced clinic-based support/counselingScheduling 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 | Active comparator | Other: ControlPatients who receive standard of care regarding embryo disposition options |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient at Boston IVF with embryos frozen in storage
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced clinic-based support/counselingAdditional 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 |
| Control | Other | Patients receiving standard of care |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 31415660Zimon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Zimon, MD principal investigator
Boston IVF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced clinic-based support/counseling in people with Infertility, run by Boston IVF at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in embryo donation (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.