Psychological Stress Clinical Trial
Official title:
Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?
Verified date | July 2011 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 131 |
Est. completion date | June 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived Stress Scale Scores | The perceived stress scale is a validated instrument to assess psychological stress | Day of embryo transfer (day 1) and 10 days later | No |
Secondary | Patient perceived benefit | Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study. | 10 days after embryo transfer | No |
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