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

Embryo Transfer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919502
• Other study ID #: 6004
• Status: Completed
• Phase: N/A
• First received: August 5, 2013
• Last updated: May 12, 2014
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Embryo Transfer
• Intrauterine Insemination (IUI)

Intervention

Device:
• Semi-quantitative urine pregnancy test

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of SQPT results that accurately monitor pregnancy	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.	6 weeks	No
Secondary	Feasibility of women using this test at home	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.	6 weeks	No
Secondary	Acceptability of semi-quantitative pregnancy test	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.	6 weeks	No
Secondary	Effectiveness of written instructions and provider's counseling	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).	6 weeks	No