NCT01103973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

October 24, 2016

Completed
Last Updated

January 18, 2018

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

April 13, 2010

Results QC Date

September 1, 2016

Last Update Submit

December 19, 2017

Conditions

Infertility

Keywords

IVF, Mind/Body

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy Rates

    Presence of normal fetal heart rate and fetal size at 7 weeks gestation.

    1 year

Secondary Outcomes (1)

  • Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)

    1 year

Study Arms (2)

Control (Spa Certificate)

PLACEBO COMPARATOR

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

Behavioral: Control

Mind/Body Program

EXPERIMENTAL

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

Behavioral: Mind/Body Program

Interventions

Mind/Body ProgramBEHAVIORAL

Ten week group mind/body program

Mind/Body Program
ControlBEHAVIORAL

Spa gift certificates

Control (Spa Certificate)

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Prescription antipsychotic medication
  • Diagnosis of borderline or narcissistic personality disorder
  • Previous participation in a MB group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

  • 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.

    PMID: 21496800DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Alice D. Domar, PhD
Organization
Boston IVF
domar@domarcenter.com
781-434-6500

Study Officials

  • Alice D Domar, PhD

    Boston IVF

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

March 1, 2007

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

January 18, 2018

Results First Posted

October 24, 2016

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)