This trial is active, not recruiting.

Condition depression relapse in women undergoing fertility treatment
Sponsor Massachusetts General Hospital
Start date October 2012
End date June 2016
Trial size 60 participants
Trial identifier NCT01746797, 2012P001637


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Women who have selected to stay on antidepressant medication while undergoing infertility treatment.
Women who decided to discontinue their antidepressants while undergoing fertility treatments.

Primary Outcomes

Depression relapse
time frame: six months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.
Principal investigator Marlene F Freeman, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.