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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

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, Mind/Body

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

NCT ID

NCT01103973

First Posted

April 13, 2010

Last Updated

December 19, 2017

Sponsor

Boston IVF

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

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

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

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

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

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The Impact of Distress on the IVF Outcome

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