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OpenTrials
Completed

NCT Number: NCT01406028

Does Emotional Support Decrease In Vitro Fertilization Stress?

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phone calls

Behavioral

Phone calls to offer emotional support

Primary outcomes

  1. 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

  1. Patient perceived benefit

    Time frame: 10 days after embryo transfer

    Exit questionnaires were administered 10 days after transfer to assess patient perceptions of the study.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2011
Registry last updated
Jul 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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