The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)

The Effect of SSRI Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing In Vitro Fertilization for Unexplained Infertility - a Prospective Placebo-Controlled Study.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989053

Enrollment

120

Registered

2009-10-02

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2009-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, In Vitro Fertilization

Keywords

depression, anxiety, stress, antidepressant therapy, SSRI, infertility, in vitro fertilization (IVF), immunological factors, depressive and anxiety symptoms in women undergoing IVF treatment

Brief summary

Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore, stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was suggested to be involved in the process. Treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. The investigators suggest to study the efficacy of antidepressant treatment in women undergoing IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.

Interventions

DRUGescitalopram

10 mg/d for a duration of 8 weeks

DRUGplacebo

1 pill per day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. Women 18 - 45 y.o. 2. A score higher then 45 on the Zung Self-Rating Anxiety Scale or a score higher then 16 on the Center for Epidemiologic Studies Depression Scale 3. Understanding of Hebrew 4. Willing to sign the informed consent

Exclusion criteria

1. An axis I DSM IVTR diagnosis other then a depressive, adjustment or anxiety disorder 2. Suicidal ideation 3. Current treatment with antidepressant medication 4. Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.) 5. Alcoholism or drug abuse and dependence 6. Past severe side effects to SSRIs 7. Failed IVF (4 trials of good quality embryo reinstatement without achieving pregnancy)

Design outcomes

Primary

Measure	Time frame
positive blood βHCG	2 months from date of signing informed consent

Secondary

Measure	Time frame
psychiatric evaluation questionnaires	2 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026