Does Emotional Support Decrease In Vitro Fertilization Stress?

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01406028
First received: July 28, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention
In Vitro Fertilization
Psychological Stress
Behavioral: Phone calls

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Perceived Stress Scale Scores [ Time Frame: Day of embryo transfer (day 1) and 10 days later ] [ Designated as safety issue: No ]
    The perceived stress scale is a validated instrument to assess psychological stress


Secondary Outcome Measures:
  • Patient perceived benefit [ Time Frame: 10 days after embryo transfer ] [ Designated as safety issue: No ]
    Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.


Enrollment: 131
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
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.
Active Comparator: Intervention phone calls
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.
Behavioral: Phone calls
Phone calls to offer emotional support

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406028

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Rachel K. Ashby, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01406028     History of Changes
Other Study ID Numbers: 2009p-001214
Study First Received: July 28, 2011
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
IVF
Stress
Infertility

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 21, 2014