Clinical trial NCT01746797: Symptom Tracking in Assisted Reproductive Technologies
Official title: Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression Relapse in Women Undergoing Fertility Treatment
Keywords: infertility
depression
IVF
IUI
fertility treatment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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.

Primary outcomes:
measure: Depression relapse
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marlene F Freeman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Lee S Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: