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

Infertility Clinical Trial

Official title:

The Impact of an Online Stress Management Program on IVF Outcome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01156324
• Other study ID #: 20100765
• Status: Withdrawn
• Phase: N/A
• First received: June 29, 2010
• Last updated: February 3, 2016
• Start date: July 2010
• Est. completion date: August 2010

Study information

• Verified date: February 2016
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• Online Stress Management Group (Upliv)
Personalized online stress management program
• Control
Control group receiving routine care along with $50 gift certificate at end of cycle

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	Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.	1 year	No
Secondary	Psychological Status	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.	1 year	No