Does Emotional Support Decrease In Vitro Fertilization Stress?

Study Overview
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Brief Summary
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In vitro fertilization for infertility has been associated with a significant amount of treatment related stress for patients. In addition,stress levels increase between embryo transfer and pregnancy test, during this waiting period. The investigators evaluated whether or not brief interventions by phone by trained social workers influenced stress levels. Our data showed that these interventions did not change levels, but confirmed that stress did increase during this time and that patients report wanting additional emotional support to improve stress during this period.

Official Title
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Does Emotional Support During the Luteal Phase Decrease the Stress of IVF?

Conditions
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In Vitro Fertilization, Psychological Stress

Intervention / Treatment
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* Behavioral: Phone calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women (ages 18-45) undergoing their first fresh cycle of IVF using autologous oocytes where an embryo transfer occurred Exclusion Criteria: > 2nd cycle of IVF IVF using donor eggs or a gestational carrier Transfers with Cryopreserved embryos Day 5 embryo transfers Self-reported history of depression or anxiety Already seeing a mental health professional Inability to speak or read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of care includes discharge instructions from one of our IVF nurses regarding medications and timing of follow-up, at which point patients are told what day they need to return for their pregnancy test. Patients have access to phone numbers for their IVF nurses and physicians, as well as information about how to contact the social workers if additional support is needed. They also are provided the emergency phone numbers for after-hour calls to the fellow on call. However, during the time between the embryo transfer and the pregnancy test, the current standard of care is that contact between the patient and our team is patient-initiated. | |
| Active Comparator: Intervention phone calls<br>The intervention consisted of two phone calls from an IVF social worker during the time between embryo transfer and pregnancy test. The first phone call occurred between days 2-4 after transfer and the second phone call occurred between days 5 and 9 after embryo transfer. Standard language for introductions to phone calls and for voice mails was established prior to the start of the study. | Behavioral: Phone calls<br>* Phone calls to offer emotional support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale Scores | The perceived stress scale is a validated instrument to assess psychological stress | Day of embryo transfer (day 1) and 10 days later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perceived benefit | Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study. | 10 days after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Stress, Infertility