The Impact of Distress on the IVF Outcome

This study has been completed.
Sponsor:
Information provided by:
Boston IVF
ClinicalTrials.gov Identifier:
NCT01103973
First received: April 13, 2010
Last updated: April 14, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Infertility
Behavioral: Mind/Body Program
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Distress on the IVF Outcome

Resource links provided by NLM:


Further study details as provided by Boston IVF:

Primary Outcome Measures:
  • Clinical Pregnancy Rates [ Time Frame: 2 IVF Cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological Status [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Psychological status is assessed by the following scales: Derogatis Affect Balance Scale (DABS), Perceived Stress Scale (PSS), State Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Fertility Problem Inventory (FPI), Infertility Self Efficacy Scale (ISES), Social Readjustment Scale (SRS), Short Form Health Survey (SF-36), Daily Monitoring Form (DMF). Other than the DMF, these are all published validated scales.


Enrollment: 143
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control (Spa Certificate)
For every three months in the study control subjects received $50 spa gift certificates.
Behavioral: Control
Spa gift certificates
Experimental: Mind/Body Program
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Behavioral: Mind/Body Program
Ten week group mind/body program

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

  • Prescription antipsychotic medication
  • Diagnosis of borderline or narcissistic personality disorder
  • Previous participation in a MB group
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103973

Locations
United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Boston IVF
Investigators
Principal Investigator: Alice D Domar, PhD Boston IVF
  More Information

No publications provided by Boston IVF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice D. Domar, PhD, Boston IVF
ClinicalTrials.gov Identifier: NCT01103973     History of Changes
Other Study ID Numbers: 20070076
Study First Received: April 13, 2010
Last Updated: April 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Boston IVF:
IVF, Mind/Body

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 20, 2014