Symptom Tracking in Assisted Reproductive Technologies

Depression Relapse in Women Undergoing Fertility Treatment Clinical Trial

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Official title:

Symptom Tracking in Women With a History of Depression Going Through Infertility Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746797
• Other study ID #: 2012P001637
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: January 16, 2018
• Start date: October 2012
• Est. completion date: January 16, 2018

Study information

• Verified date: January 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 16, 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression Relapse in Women Undergoing Fertility Treatment
• Depressive Disorder

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression relapse		six months