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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Embryo Transfer Intrauterine Insemination (IUI)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Semi-quantitative urine pregnancy test

Semi-quantitative urine pregnancy test (Quanti5 Multilevel hCG Pregnancy Test)

Group Type OTHER

Semi-quantitative urine pregnancy test

Intervention Type DEVICE

Interventions

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Semi-quantitative urine pregnancy test

Intervention Type DEVICE

Other Intervention Names

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Quanti5 Multilevel hCG Pregnancy Test

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes