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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01406028
Other study ID # 2009p-001214
Secondary ID
Status Completed
Phase N/A
First received July 28, 2011
Last updated July 28, 2011
Start date September 2009
Est. completion date June 2010

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care


Intervention

Behavioral:
Phone calls
Phone calls to offer emotional support

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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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