Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01919502
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : May 14, 2014
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE August 5, 2013
First Posted Date  ICMJE August 9, 2013
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE October 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01919502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Official Title  ICMJE Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Embryo Transfer
  • Intrauterine Insemination (IUI)
Intervention  ICMJE Device: Semi-quantitative urine pregnancy test
Other Name: Quanti5 Multilevel hCG Pregnancy Test
Study Arms  ICMJE Semi-quantitative urine pregnancy test
Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test)
Intervention: Device: Semi-quantitative urine pregnancy test
Publications * Shochet T, Comstock IA, Ngoc NTN, Westphal LM, Sheldon WR, Loc LT, Blum J, Winikoff B, Blumenthal PD. Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction. BMC Womens Health. 2017 Aug 22;17(1):67. doi: 10.1186/s12905-017-0422-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
51
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
50
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01919502
Other Study ID Numbers  ICMJE 6004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Stanford University
Investigators  ICMJE
Principal Investigator: Lynn Westphal, MD Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine
Principal Investigator: Paul Blumenthal, MD, MPH Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine
Principal Investigator: Wendy Sheldon, MPH, MSW, PhD Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP