Clinical trial NCT01919502: Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Official title: Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Transfer
Intrauterine Insemination (IUI)
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2013-08-09
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of SQPT results that accurately monitor pregnancy
timeFrame: 6 weeks
Secondary outcomes:
measure: Feasibility of women using this test at home
timeFrame: 6 weeks
measure: Acceptability of semi-quantitative pregnancy test
timeFrame: 6 weeks
measure: Effectiveness of written instructions and provider's counseling
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine
name: Lynn Westphal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine
name: Paul Blumenthal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Wendy Sheldon, MPH, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.