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Does Emotional Support Decrease In Vitro Fertilization Stress?

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ClinicalTrials.gov Identifier: NCT01406028
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:
Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE July 28, 2011
First Posted Date  ICMJE July 29, 2011
Last Update Posted Date July 29, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Emotional Support Decrease In Vitro Fertilization Stress?
Official Title  ICMJE Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • In Vitro Fertilization
  • Psychological Stress
Intervention  ICMJE Behavioral: Phone calls
Phone calls to offer emotional support
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Phone calls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2011)
131
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01406028
Other Study ID Numbers  ICMJE 2009p-001214
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rachel K. Ashby, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP