The Impact of Distress on the IVF Outcome

Infertility Clinical Trial

Official title:

The Impact of Distress on the IVF Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103973
• Other study ID #: 20070076
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: December 19, 2017
• Start date: March 2007
• Est. completion date: November 2009

Study information

• Verified date: December 2017
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Prescription antipsychotic medication

• Diagnosis of borderline or narcissistic personality disorder

• Previous participation in a MB group

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• Mind/Body Program
Ten week group mind/body program
• Control
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Locations

Country	Name	City	State
United States	Boston IVF	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston IVF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rates	Presence of normal fetal heart rate and fetal size at 7 weeks gestation.	1 year
Secondary	Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)	Psychological status is assessed by the Beck Depression Inventory (BDI). The scores range from 0 to 63; a score of 0 being no depression and 63 being severely depressed. Our cut-off for normal was a score of 12 or less, and those with a score of 13 or greater were considered to have symptoms of depression.	1 year