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Clinical Trials/NCT01406028
NCT01406028
Completed
Not Applicable

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

Brigham and Women's Hospital1 site in 1 country131 target enrollmentSeptember 2009
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ConditionsIn Vitro FertilizationPsychological Stress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
In Vitro Fertilization
Sponsor
Brigham and Women's Hospital
Enrollment
131
Locations
1
Primary Endpoint
Perceived Stress Scale Scores
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
June 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perceived Stress Scale Scores

Time Frame: Day of embryo transfer (day 1) and 10 days later

The perceived stress scale is a validated instrument to assess psychological stress

Secondary Outcomes

  • Patient perceived benefit(10 days after embryo transfer)

Study Sites (1)

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