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Completed

NCT Number: NCT01919502

Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment

Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, the investigators would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot will help us to better understand how this tool complements existing monitoring protocols. If a suitable addition or replacement to repeat blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make assisted fertility treatments more patient-friendly. This study seeks to test this innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg retrieval/embryo transfer or intrauterine insemination.

The investigators hypothesize that the test, which can be used at home by women, will provide confirmation of the presence of a pregnancy compared with standard serum hCG testing because 1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can be used at home and thus earlier to determine presence of hCG.

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Key information

Conditions

Embryo Transfer Intrauterine Insemination (IUI)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Planning embryo transfer or intrauterine insemination (IUI)
  • Agrees to return for a series of follow-up visits
  • Willing to follow provider instructions regarding use of at-home pregnancy test
  • Has not already participated in this study (each woman can only participate once)
  • Able to read and write in English
  • Willing to provide an address and/or telephone number to be contacted for purposes of follow-up
  • Willing and able to consent to study participation

Exclusion criteria

  • Does not agree to return for a series of follow-up visits
  • Not willing to follow provider instructions regarding use of at-home pregnancy test
  • Has already participated in this study (each woman can only participate once)
  • Not able to read and write in English
  • Not willing to provide an address and/or telephone number to be contacted for purposes of follow-up
  • Not willing and able to consent to study participation

Treatment and study plan

Semi-quantitative urine pregnancy test

Device

Other names: Quanti5 Multilevel hCG Pregnancy Test

Primary outcomes

  1. Proportion of SQPT results that accurately monitor pregnancy

    Time frame: 6 weeks

    Participants will have follow-up visits that include serum hCG testing and ultrasounds to confirm pregnancy. Will be able to compare these results to the results of the at-home pregnancy test.

Secondary outcomes

  1. Feasibility of women using this test at home

    Time frame: 6 weeks

    Feasibility of women using this test at home on their own as a potential future substitute or complement to standard sequential clinic-based visits to monitor pregnancy after embryo transfer or IUI. Forms given to document their results at home will include questions on feasibility. Exit interview will also include questions regarding feasibility.

  2. Acceptability of semi-quantitative pregnancy test

    Time frame: 6 weeks

    Acceptability of using semi-quantitative pregnancy at home instead of tests standard clinic-based monitoring after embryo transfer or IUI. Forms given to document their results at home will include questions on acceptability. Exit interview will also include questions regarding acceptability.

  3. Effectiveness of written instructions and provider's counseling

    Time frame: 6 weeks

    Assess if written instructions and provider's counseling enable women using the semi-quantitative pregnancy test at home to understand how it should be used and to correctly interpret the test result. Forms given to document their results at home will include questions on whether the oral and written instructions helped interpret the results. Exit interview will be conducted to determine how the additional information made the participant feel about conducting the test (i.e. more relaxed, less relaxed, or no difference).

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Stanford University

Registry information

Official study title

Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 9, 2013
Registry last updated
May 14, 2014

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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