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

NCT ID: NCT01156324

Last Updated: 2016-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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.

Group Type PLACEBO_COMPARATOR

Online Stress Management Group (Upliv)

Intervention Type BEHAVIORAL

Personalized online stress management program

Online Stress Management Group (Upliv)

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.

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Control group receiving routine care along with $50 gift certificate at end of cycle

Interventions

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Online Stress Management Group (Upliv)

Personalized online stress management program

Intervention Type BEHAVIORAL

Control

Control group receiving routine care along with $50 gift certificate at end of cycle

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Exclusion Criteria

* prescription antipsychotic medication
* previous diagnosis of borderline or narcissistic personality disorder
* previous or concurrent participation in a mind/body group
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston IVF

OTHER

Sponsor Role lead

Responsible Party

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Alice D. Domar, PhD

Alice D. Domar, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alice D Domar, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston IVF

Locations

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Boston IVF

Waltham, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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20100765

Identifier Type: -

Identifier Source: org_study_id

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