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The Impact of Distress on the IVF Outcome

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ClinicalTrials.gov Identifier: NCT01103973
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : October 24, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Infertility Behavioral: Mind/Body Program Behavioral: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Distress on the IVF Outcome
Study Start Date : March 2007
Primary Completion Date : September 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical Pregnancy Rates [ Time Frame: 1 year ]
    Presence of normal fetal heart rate and fetal size at 7 weeks gestation.


Secondary Outcome Measures :
  1. Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) [ Time Frame: 1 year ]
    Psychological status is assessed by the Beck Depression Inventory (BDI). The scores range from 0 to 63; a score of 0 being no depression and 63 being severely depressed. Our cut-off for normal was a score of 12 or less, and those with a score of 13 or greater were considered to have symptoms of depression.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston IVF
ClinicalTrials.gov Identifier: NCT01103973     History of Changes
Other Study ID Numbers: 20070076
First Posted: April 15, 2010    Key Record Dates
Results First Posted: October 24, 2016
Last Update Posted: January 18, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston IVF:
IVF, Mind/Body

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