Back to resultsDoes Emotional Support Decrease In Vitro Fertilization Stress?
Primary Purpose
In Vitro Fertilization, Psychological Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone calls
Sponsored by
About this trial
This is an interventional supportive care trial for In Vitro Fertilization focused on measuring IVF, Stress, Infertility
Eligibility Criteria
Inclusion Criteria:
- All women (ages 18-45) undergoing their first fresh cycle of IVF using autologous oocytes where an embryo transfer occurred
Exclusion Criteria:
- > 2nd cycle of IVF IVF using donor eggs or a gestational carrier
- Transfers with Cryopreserved embryos
- Day 5 embryo transfers
- Self-reported history of depression or anxiety
- Already seeing a mental health professional
- Inability to speak or read English
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard of Care
Intervention phone calls
Arm Description
Standard of care includes discharge instructions from one of our IVF nurses regarding medications and timing of follow-up, at which point patients are told what day they need to return for their pregnancy test. Patients have access to phone numbers for their IVF nurses and physicians, as well as information about how to contact the social workers if additional support is needed. They also are provided the emergency phone numbers for after-hour calls to the fellow on call. However, during the time between the embryo transfer and the pregnancy test, the current standard of care is that contact between the patient and our team is patient-initiated.
The intervention consisted of two phone calls from an IVF social worker during the time between embryo transfer and pregnancy test. The first phone call occurred between days 2-4 after transfer and the second phone call occurred between days 5 and 9 after embryo transfer. Standard language for introductions to phone calls and for voice mails was established prior to the start of the study.
Outcomes
Primary Outcome Measures
Perceived Stress Scale Scores
The perceived stress scale is a validated instrument to assess psychological stress
Secondary Outcome Measures
Patient perceived benefit
Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.
Full Information
NCT ID
NCT01406028
First Posted
July 28, 2011
Last Updated
July 28, 2011
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01406028
Brief Title
Does Emotional Support Decrease In Vitro Fertilization Stress?
Official Title
Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In vitro fertilization for infertility has been associated with a significant amount of treatment related stress for patients. In addition,stress levels increase between embryo transfer and pregnancy test, during this waiting period. The investigators evaluated whether or not brief interventions by phone by trained social workers influenced stress levels. Our data showed that these interventions did not change levels, but confirmed that stress did increase during this time and that patients report wanting additional emotional support to improve stress during this period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Vitro Fertilization, Psychological Stress
Keywords
IVF, Stress, Infertility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care includes discharge instructions from one of our IVF nurses regarding medications and timing of follow-up, at which point patients are told what day they need to return for their pregnancy test. Patients have access to phone numbers for their IVF nurses and physicians, as well as information about how to contact the social workers if additional support is needed. They also are provided the emergency phone numbers for after-hour calls to the fellow on call. However, during the time between the embryo transfer and the pregnancy test, the current standard of care is that contact between the patient and our team is patient-initiated.
Arm Title
Intervention phone calls
Arm Type
Active Comparator
Arm Description
The intervention consisted of two phone calls from an IVF social worker during the time between embryo transfer and pregnancy test. The first phone call occurred between days 2-4 after transfer and the second phone call occurred between days 5 and 9 after embryo transfer. Standard language for introductions to phone calls and for voice mails was established prior to the start of the study.
Intervention Type
Behavioral
Intervention Name(s)
Phone calls
Intervention Description
Phone calls to offer emotional support
Primary Outcome Measure Information:
Title
Perceived Stress Scale Scores
Description
The perceived stress scale is a validated instrument to assess psychological stress
Time Frame
Day of embryo transfer (day 1) and 10 days later
Secondary Outcome Measure Information:
Title
Patient perceived benefit
Description
Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.
Time Frame
10 days after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All women (ages 18-45) undergoing their first fresh cycle of IVF using autologous oocytes where an embryo transfer occurred
Exclusion Criteria:
> 2nd cycle of IVF IVF using donor eggs or a gestational carrier
Transfers with Cryopreserved embryos
Day 5 embryo transfers
Self-reported history of depression or anxiety
Already seeing a mental health professional
Inability to speak or read English
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Does Emotional Support Decrease In Vitro Fertilization Stress?
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