Does Emotional Support Decrease In Vitro Fertilization Stress?

Psychological Stress Clinical Trial

Official title:

Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406028
• Other study ID #: 2009p-001214
• 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

Related Conditions & MeSH terms

• In Vitro Fertilization
• Psychological Stress
• Stress, Psychological

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