Symptom Tracking in Assisted Reproductive Technologies (START)

January 16, 2018 updated by: Marlene P. Freeman, MD, Massachusetts General Hospital

Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression relapse
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Marlene F Freeman, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

January 16, 2018

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P001637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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