The Impact of Distress on the IVF Outcome

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Distress on the IVF Outcome

Conditions
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Infertility

Intervention / Treatment
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* Behavioral: Mind/Body Program
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control (Spa Certificate)<br>For every three months in the study control subjects received $50 spa gift certificates. | Behavioral: Control<br>* Spa gift certificates<br>|
| Experimental: Mind/Body Program<br>Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications. | Behavioral: Mind/Body Program<br>* Ten week group mind/body program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rates | Presence of normal fetal heart rate and fetal size at 7 weeks gestation. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Mind/Body