The Impact of Distress on the IVF Outcome
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind/Body Program
Control
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, Mind/Body
Eligibility 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
Sites / Locations
- Boston IVF
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control (Spa Certificate)
Mind/Body Program
Arm Description
For every three months in the study control subjects received $50 spa gift certificates.
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Outcomes
Primary Outcome Measures
Clinical Pregnancy Rates
Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
Secondary Outcome Measures
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01103973
Brief Title
The Impact of Distress on the IVF Outcome
Official Title
The Impact of Distress on the IVF Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston IVF
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, Mind/Body
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control (Spa Certificate)
Arm Type
Placebo Comparator
Arm Description
For every three months in the study control subjects received $50 spa gift certificates.
Arm Title
Mind/Body Program
Arm Type
Experimental
Arm Description
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Intervention Type
Behavioral
Intervention Name(s)
Mind/Body Program
Intervention Description
Ten week group mind/body program
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Spa gift certificates
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rates
Description
Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice D Domar, PhD
Organizational Affiliation
Boston IVF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21496800
Citation
Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.
Results Reference
derived
Learn more about this trial
The Impact of Distress on the IVF Outcome
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