Symptom Tracking in Assisted Reproductive Technologies (START)
This study assesses risk factors for depressive relapse in women undergoing fertility treatment with histories of major depressive disorder (MDD) 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.
Depression Relapse in Women Undergoing Fertility Treatment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.|
- Depression relapse [ Time Frame: six months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
samples obtained with permission from participant and stored for future proteomic research
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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.
This study hopes to address the following aims:
Specific Aim #1: To delineate the relative risk of relapse in women across treatment with IVF 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.
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 treatment.
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 treatment.
Hypothesis: Hypothalamic-pituitary-adrenal (HPA) axis dysregulation, evidenced by increases in diurnal salivary cortisol patterns and markers of inflammation, will be associated with higher
|Contact: Marlene F Freeman, MDfirstname.lastname@example.org|
|Contact: Maria M Barsky, ABemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Sub-Investigator: Lee S Cohen, MD|
|Principal Investigator: Marlene F Freeman, MD|
|Principal Investigator:||Marlene F Freeman, MD||Massachusetts General Hospital|
|Principal Investigator:||Lee S Cohen, MD||Massachusetts General Hospital|