Does Emotional Support Decrease In Vitro Fertilization Stress?

NCT01406028 | Completed

• 1 other identifier: 2009p-001214
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

In Vitro Fertilization; Psychological Stress

Keywords

IVF; Stress; Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient perceived benefit

  10 days after embryo transfer

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Intervention phone calls

ACTIVE COMPARATOR

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

Interventions

Phone calls BEHAVIORAL

Phone calls to offer emotional support

Intervention phone calls

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All women (ages 18-45) undergoing their first fresh cycle of IVF using autologous oocytes where an embryo transfer occurred

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Infertility

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 29, 2011

Record last verified: 2011-07

Locations

US (1)