Symptom Tracking in Assisted Reproductive Technologies

NCT ID: NCT01746797

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-01-16

Brief Summary

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.

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

Conditions

Depression Relapse in Women Undergoing Fertility Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women currently taking antidepressants

Women who have selected to stay on antidepressant medication while undergoing infertility treatment.

No interventions assigned to this group

Women not on antidepressants

Women who decided to discontinue their antidepressants while undergoing fertility treatments.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marlene P. Freeman, MD

Director of Clinical Services at the Center for Women's Mental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marlene F Freeman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Lee S Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2012P001637

Identifier Type: -

Identifier Source: org_study_id