NCT01103973

The Impact of Distress on the IVF Outcome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Boston IVF · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C). This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.

Conditions

• Infertility

Interventions

Type	Name	Description
BEHAVIORAL	Mind/Body Program	Ten week group mind/body program
BEHAVIORAL	Control	Spa gift certificates

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-09-01
• Completion: 2009-11-01
• First posted: 2010-04-15
• Last updated: 2018-01-18
• Results posted: 2016-10-24

Locations

1 site across 1 country: United States