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

Gynuity Health Projects

Status

Completed

Conditions

Embryo Transfer

Treatments

Device: Semi-quantitative urine pregnancy test

Study type

Interventional

Funder types

Other

Identifiers

NCT01846403

6002

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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