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

NCT01919502 | Completed

• 1 other identifier: 6004
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Embryo Transfer; Intrauterine Insemination (IUI)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Feasibility of women using this test at home

  6 weeks

• Acceptability of semi-quantitative pregnancy test

  6 weeks

• Effectiveness of written instructions and provider's counseling

  6 weeks

Study Arms (1)

Semi-quantitative urine pregnancy test

OTHER

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

Device: Semi-quantitative urine pregnancy test

Interventions

Semi-quantitative urine pregnancy test DEVICE

Also known as: Quanti5 Multilevel hCG Pregnancy Test

Semi-quantitative urine pregnancy test

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 28830483 DERIVED

Study Officials

• Lynn Westphal, MD

  Division of Reproductive Endocrinology and Infertility Stanford University School of Medicine

  PRINCIPAL INVESTIGATOR

• Paul Blumenthal, MD, MPH

  Dept of Obstetrics and Gynecology, Stanford University, Stanford University School of Medicine

  PRINCIPAL INVESTIGATOR

• Wendy Sheldon, MPH, MSW, PhD

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 9, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (1)