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Symptom Tracking in Assisted Reproductive Technologies (START)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746797
First Posted: December 11, 2012
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
  Purpose

This study assesses risk factors for depressive relapse in women undergoing fertility treatment with histories of major depressive disorder (MDD) or bipolar disorder. The study is focused on the acute risk factors of depressive relapse.

The investigators hypothesize that risk for depressive relapse will be greater among women who stop antidepressants compared to those who continue treatment with these agents.


Condition
Depression Relapse in Women Undergoing Fertility Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.

Further study details as provided by Marlene P. Freeman, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Depression relapse [ Time Frame: six months ]

Biospecimen Retention:   Samples With DNA
samples obtained with permission from participant and stored for future proteomic research

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: August 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women currently taking antidepressants
Women who have selected to stay on antidepressant medication while undergoing infertility treatment.
Women not on antidepressants
Women who decided to discontinue their antidepressants while undergoing fertility treatments.

Detailed Description:

This study hopes to address the following aims:

Specific Aim #1: To delineate the relative risk of relapse in women undergoing IVF, IUI, or other infertility treatments who discontinue antidepressant therapy for depression, compared to those who maintain treatment with these agents.

Hypothesis: Risk for depressive relapse will be greater among women who stop antidepressants compared to those who continue treatment with these agents.

Specific Aim #2: To identify predictors of depressive relapse among women receiving IVF, IUI, or other infertility treatments

Hypothesis: Relapse rates will be greater among those who have: 1) histories of more recurrent depressive illness, 2) longer duration of attempt to conceive, and 3) a lower degree of perceived support from respective partners.

Specific Aim #3 (exploratory): To describe the trajectory of depressive symptoms in women with histories of depression across the course of IVF, IUI, or other treatments.

Hypothesis: Specific phases of the IVF cycle will have differential effects on the burden of depressive symptoms. Specifically, these phases include: 1) the phase prior to egg retrieval, 2) the phase after embryo transfer while a woman waits for the pregnancy test or her menstrual period, and 3) the phase after the experience of a negative pregnancy test (when applicable) following an IVF cycle. We seek to characterize factors associated both with vulnerability to more depressive symptoms and to resilience in the context of the different phases of IVF treatment.

Specific Aim #4 (exploratory): To identify biological markers of stress, including HPA axis dysregulation and inflammation associated with depressive relapse, during IVF, IUI, or other infertility treatments

Hypothesis: Hypothalamic-pituitary-adrenal (HPA) axis dysregulation, evidenced by increases in diurnal salivary cortisol patterns and markers of inflammation, will be associated with higher

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will include 60 women 18 years and older with histories of depression or bipolar disorder who are planning infertility treatment, specifically in utero insemination (IUI) or in vitro fertilization (IVF).
Criteria

Inclusion Criteria:

  • Have a history of a MDE or bipolar disorder prior to starting fertility treatment.
  • Have received consultation around infertility treatment and plan to start fertility treatment.

Exclusion Criteria:

  • Use of corticosteroids within 1 month of enrollment.
  • Presence of any endocrine or autoimmune disorder, other than hypothyroidism well-treated for at least 6 months.
  • Current episode of depression or mania.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746797


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Marlene F Freeman, MD Massachusetts General Hospital
Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
  More Information

Responsible Party: Marlene P. Freeman, MD, Director of Clinical Services at the Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01746797     History of Changes
Other Study ID Numbers: 2012P001637
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Marlene P. Freeman, MD, Massachusetts General Hospital:
infertility
depression
IVF
IUI
fertility treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs