Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

NCT ID: NCT01714882

Last Updated: 2015-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-09-30

Brief Summary

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The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).

Detailed Description

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The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stress Management & Resiliency Training

The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.

Group Type EXPERIMENTAL

Stress Management & Resiliency Training

Intervention Type BEHAVIORAL

The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.

Stress Management DVD

The couples in this group will receive a Mayo Clinic Stress Management DVD.

Group Type ACTIVE_COMPARATOR

Stress Management DVD

Intervention Type BEHAVIORAL

The couples in this group will receive a Mayo Clinic Stress Management DVD.

Interventions

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Stress Management & Resiliency Training

The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.

Intervention Type BEHAVIORAL

Stress Management DVD

The couples in this group will receive a Mayo Clinic Stress Management DVD.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
* Women with a partner, and both are willing to provide consent for study participation as a couple
* Couples that can be reached by telephone for follow-up

Exclusion Criteria

* Women less than 18 years of age
* Women equal or greater than 40 years of age
* Women with a history of recurrent pregnancy loss
* History of current or recent psychotic episode within past 6 months for either the woman or her partner
* Couples needing a interpreter for their clinical encounter
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amit Sood

OTHER

Sponsor Role lead

Responsible Party

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Amit Sood

Associate Professor of Medicine, Consultant - General Internal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amit Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Zaraq Khan, MBBS

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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12-007272

Identifier Type: -

Identifier Source: org_study_id

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