The Impact of Distress on the IVF Outcome

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Behavioral: Mind/Body Program; Behavioral: Control

• Registration Number: NCT01103973
• Lead Sponsor: Boston IVF

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Results First Submitted: 2016-09-01
• Results First Submitted QC: 2016-09-01
• Results First Posted: 2016-10-24
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mind/Body Program	Mind/Body Program	Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Control (Spa Certificate)	Control	For every three months in the study control subjects received $50 spa gift certificates.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rates	1 year	Presence of normal fetal heart rate and fetal size at 7 weeks gestation.

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)	1 year	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.

Trial Locations

Locations (1)

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States