Symptom Tracking in Assisted Reproductive Technologies (START)
|ClinicalTrials.gov Identifier: NCT01746797|
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : January 18, 2018
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 or disease|
|Depression Relapse in Women Undergoing Fertility Treatment|
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|
|Actual Enrollment :||49 participants|
|Official Title:||Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.|
|Study Start Date :||October 2012|
|Primary Completion Date :||June 2016|
|Study Completion Date :||January 16, 2018|
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.
- Depression relapse [ Time Frame: six months ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746797
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Marlene F Freeman, MD||Massachusetts General Hospital|
|Principal Investigator:||Lee S Cohen, MD||Massachusetts General Hospital|