The Impact of Distress on the IVF Outcome
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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 |
- Clinical Pregnancy Rates [ Time Frame: 2 IVF Cycles ] [ Designated as safety issue: No ]
- 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 |
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 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 May 21, 2013