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Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test in an Assisted Fertility Setting

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ClinicalTrials.gov Identifier: NCT01846403
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE May 1, 2013
First Posted Date  ICMJE May 3, 2013
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
Document whether continuing pregnancy can be successfully monitored at home using a semi-quantitative pregnancy test [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01846403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
  • 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. [ Time Frame: 6 weeks ]
  • Women's acceptability of using pregnancy tests at home instead of standard clinic-based monitoring after embryo transfer [ 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 [ Time Frame: 6 weeks ]
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 Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test in an Assisted Fertility Setting
Official Title  ICMJE Feasibility and Acceptability of Using the Semi-quantitative Pregnancy Test to Replace Sequential Serum hCG Testing in an Assisted Fertility Setting
Brief Summary

Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, we 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, 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 dBest® semi-quantitative urine panel test (AmeriTekInc, Seattle WA, USA)at home on a weekly basis for up to 4 weeks after embryo transfer.

We 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. Furthermore, a pregnancy can be assured only when a yolksac or embryo could be identified thus women have to wait for a period of 2-3 weeks after the next menses expected.

We hypothesize that women seeking assisted fertility treatments will be able to monitor their hCG at home as well. Further, we plan to develop revised instructions to better suit the needs and questions we think would be relevant to women desiring to use this test as part of assisted fertility services.

We hypothesize that the simple instructions we will develop for use in this study will enable women to use the test on their own. Provider counseling will complement these instructions and contribute to overall quality of care given to each participant.

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
Intervention  ICMJE Device: Semi-quantitative urine pregnancy test
Other Name: (dBest One Step hCG Panel Test Kit)
Study Arms  ICMJE Semi-quantitative pregnancy test
Semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit)
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 1, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligible for assisted fertility treatment according to hospital guidelines
  • Agrees to have blood drawn several times for serum hCG tests
  • Agrees to return for a series of follow-up visits
  • Willing to follow provider instructions regarding use of at-home pregnancy test
  • 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:

  • Women not eligible for assisted fertility treatment
  • Women who do not agree to have blood drawn several times for serum hCG tests
  • Women who do not agree return for a series of follow-up visits
  • Women unable to follow provider instructions regarding use of at-home pregnancy test
  • Women unable to provide contact information
  • Women unable to sign the consent form
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, 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 Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01846403
Other Study ID Numbers  ICMJE 6002
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 Not Provided
Investigators  ICMJE
Principal Investigator: Nguyen Thi Nhu Ngoc, MD Center for Research and Consultancy in Reproductive Health
Principal Investigator: Ly Thai Loc, MD Hungvuong Hospital
Principal Investigator: Tara Shochet, PhD, MPH Gynuity Health Projects
Principal Investigator: Paul Blumenthal, MD, MPH Stanford University
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