The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome

Not Applicable

Withdrawn

• Conditions: Infertility
• Interventions: Behavioral: Online Stress Management Group (Upliv); Behavioral: Control

• Registration Number: NCT01156324
• Lead Sponsor: Boston IVF

Brief Summary

The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.

Detailed Description

The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.

In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.

Study Timeline

• Study First Submitted: 2010-06-29
• Study Start: 2010-07
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• female Boston IVF patients
• day three FSH 12 or below
• day three estradiol 80 pg/ml or below
• able to read, understand and sign the informed consent in English
• using own eggs (not egg donor)
• willing and able to comply with study requirements
• must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week

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Exclusion Criteria

• prescription antipsychotic medication
• previous diagnosis of borderline or narcissistic personality disorder
• previous or concurrent participation in a mind/body group

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Online Stress Management Group (Upliv)	Participants of the routine care control group will each receive a $50 gift certificate at the end of each IVF cycle for which they completed the questionnaires.
Online Stress Management Group (Upliv)	Control	Personalized online stress management program consisting of weekly sessions which each include relaxation exercises, stress management strategies, and lifestyle modification advice. Participants in Upliv will also be given a set of personal care products as part of the program.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rates	1 year	Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.

Secondary Outcome Measures

Name	Time	Method
Psychological Status	1 year	Psychological status is assessed by the following scales: Perceived Stress Scale (PSS), State Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Social Readjustment Scale (SRS), Daily Monitoring Form (DMF). Other than the DMF, these are all published validated scales.

Trial Locations

Locations (1)

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States