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Does Emotional Support Decrease In Vitro Fertilization Stress?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406028
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
Information provided by:
Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
In Vitro Fertilization Psychological Stress Behavioral: Phone calls Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Perceived Stress Scale Scores [ Time Frame: Day of embryo transfer (day 1) and 10 days later ]
    The perceived stress scale is a validated instrument to assess psychological stress

Secondary Outcome Measures :
  1. Patient perceived benefit [ Time Frame: 10 days after embryo transfer ]
    Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406028

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Responsible Party: Rachel K. Ashby, MD, Brigham and Women's Hospital Identifier: NCT01406028    
Other Study ID Numbers: 2009p-001214
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011
Keywords provided by Brigham and Women's Hospital:
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms