The Impact of Distress on the IVF Outcome

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT01103973

Run by

Boston IVF

People needed

143

Starts

2007-03-01

Expected to finish

2009-11-01

Last updated by the study team

2018-01-18

Who can join

Age: 21 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female Boston IVF infertility patient
• Age 21-40 years
• Day 3 FSH level 12 mIU/ml or below
• Day 3 E2 level 80 pg/ml or below
• Using own eggs (not an egg donor)
• Daily access to the internet
• Able to read, understand, and sign the informed consent in English

You may not qualify if…

• Prescription antipsychotic medication
• Diagnosis of borderline or narcissistic personality disorder
• Previous participation in a MB group

Where it is running

• Boston IVF — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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