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OpenTrials
Completed

NCT Number: NCT01714882

Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
  • Women with a partner, and both are willing to provide consent for study participation as a couple
  • Couples that can be reached by telephone for follow-up

Exclusion criteria

  • Women less than 18 years of age
  • Women equal or greater than 40 years of age
  • Women with a history of recurrent pregnancy loss
  • History of current or recent psychotic episode within past 6 months for either the woman or her partner
  • Couples needing a interpreter for their clinical encounter

Treatment and study plan

Stress Management & Resiliency Training

Behavioral

The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.

Stress Management DVD

Behavioral

The couples in this group will receive a Mayo Clinic Stress Management DVD.

Primary outcomes

  1. Change of Scores from questionnaires from baseline to 6 and then 12 weeks

    Time frame: Baseline, 6 and 12 weeks after randomization

    Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.

Secondary outcomes

  1. Clinical Pregnancy rate

    Time frame: 12 months after randomization

    Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.

Other outcomes

  1. Clinical or biochemical miscarriage

    Time frame: 12 months after randomization

    Miscarriage will be defined as a biochemical or clinical miscarriage. A biochemical miscarriage will include a rise and then subsequent fall in beta human chorionic gonadotrophin (BhCG) to less than 5 IU/L. A clinical miscarriage will be defined as vaginal bleeding with passage of products of conception recognized as products of conception by histopathology.

Sponsors and collaborators

Lead sponsor

Amit Sood

Other

Registry information

Official study title

Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 26, 2012
Registry last updated
Nov 6, 2015

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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