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

B

Boston IVF

Status

Withdrawn

Conditions

Infertility

Treatments

Behavioral: Online Stress Management Group (Upliv)
Behavioral: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT01156324
20100765

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: Online Stress Management Group (Upliv)
Online Stress Management Group (Upliv)
Experimental group
Description:
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.
Treatment:
Behavioral: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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