The Impact of Distress on the IVF Outcome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-11-30

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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control (Spa Certificate)

For every three months in the study control subjects received $50 spa gift certificates.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

Spa gift certificates

Mind/Body Program

Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.

Group Type EXPERIMENTAL

Mind/Body Program

Intervention Type BEHAVIORAL

Ten week group mind/body program

Interventions

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Mind/Body Program

Ten week group mind/body program

Intervention Type BEHAVIORAL

Control

Spa gift certificates

Intervention Type BEHAVIORAL

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