Does Emotional Support Decrease In Vitro Fertilization Stress?

Not Applicable

Completed

• Conditions: In Vitro Fertilization; Psychological Stress
• Interventions: Behavioral: Phone calls

• Registration Number: NCT01406028
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2011-07
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Last Update Submitted: 2011-07-28
• Study First Posted: 2011-07-29
• Last Update Posted: 2011-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention phone calls	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.

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale Scores	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

Name	Time	Method
Patient perceived benefit	10 days after embryo transfer	Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States