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

Gynuity Health Projects

Status

Completed

Conditions

Embryo Transfer

Intrauterine Insemination (IUI)

Treatments

Device: Semi-quantitative urine pregnancy test

Study type

Interventional

Funder types

Other

Identifiers

NCT01919502

6004

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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