Evidence map›Paper›PMID 36050723›Full record

Trial reportReproductive biology and endocrinology : RB&E2022

Evaluation of at-home serum anti-Müllerian hormone testing: a head-to-head comparison study.

Erin Silliman, Esther H Chung, Elizabeth Fitzpatrick, Julie A Jolin, Michelle Brown, James Hotaling, Aaron K Styer, Anatte E Karmon

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Reproductive biology and endocrinology : RB&E, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04784325 (AMH^2), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.6field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04784325 nacompletednot on this map

AMH^2: Anti-Müllerian Hormone - At My Home

TypeinterventionalSponsorTurtle Health, Inc.Ran2021 to 2021Enrolled41ConditionsFertility RiskArmsBlood draw through TAP II, Blood draw through ADx cardT, Blood draw through standard venipuncture
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
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  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Erin SillimanTLC Infertility & Donor Services, 1920 Hillhurst Ave, Los Angeles, CA, 90027, USA.
Esther H ChungStanford Fertility and Reproductive Health Services, 1195 W Fremont Ave, Sunnyvale, CA, 94087, USA.
Elizabeth Fitzpatrick
Julie A JolinMassachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.
Michelle BrownNorthwestern Women's Hospital, 250 E Superior St, Chicago, IL, 60611, USA.
James HotalingUniversity of Utah 201 Presidents' Cir, Salt Lake City, UT, 84112, USA.
Aaron K StyerCCRM Fertility Boston, 300 Boylston Street, Chestnut Hill, MA, 02459, USA.
Anatte E KarmonFertility Institute of Hawaii, 1401 S Beretania St Suite 250, Honolulu, HI, 96814, USA. anatte@gmail.com.
Chestnut Hill College · USMassachusetts General Hospital · USStanford Health Care · USTLC Precision Wafer Technology (United States) · USUniversity of Utah · USWomen's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor optimal fertility testing, serum anti-Müllerian hormone levels are used in combination with other testing to provide reliable ovarian reserve evaluations. The use of the ADx 100 card is widely commercially available for at-home reproductive hormone testing, but data demonstrating that its results are reproducible outside of a clinical setting are limited, as well as comparisons of its performance with other newer blood collection techniques. This study aimed to evaluate the concordance of serum AMH levels found via standard venipuncture and self-administered blood collection using the TAP II device (TAP) and ADx card in women of reproductive age.

methodsThis was a prospective, head-to-head-to-head within-person crossover comparison trial that included 41 women of reproductive age (20-39 years). It was hypothesized that the TAP device would be superior to the ADx card both in terms of agreement with venipuncture reference standard and patient experience. Each subject had their blood drawn using the three modalities (TAP, ADx, and venipuncture). We evaluated the concordance of AMH assays from samples obtained via the TAP device and ADx card with the gold standard being venipuncture. Two-sided 95% CIs were generated for each method to compare relative performance across all three modes. Patient preference for the TAP device versus the ADx card was based on self-reported pain and Net Promoter Score (NPS).

resultsThe TAP device was superior to the ADx card on all outcome measures. TAP R-squared with venipuncture was 0.99 (95% CI 0.99, > 0.99), significantly higher than the ADx card, which had an R-squared of 0.87 (95% CI 0.80, 0.94) under most favorable treatment. TAP sensitivity and specificity were both 100% (no clinical disagreement with venipuncture), versus 100 and 88%, respectively, for the ADx card. Average pain reported by users of the TAP device was significantly lower than the ADx card (0.75 versus 2.73, p < 0.01) and the NPS was significantly higher than the ADx card (+ 72 versus - 48, p < 0.01).

conclusionsThe TAP was non-inferior to venipuncture and superior to the ADx card with respect to correlation and false positives. Moreover, the TAP was superior to both alternatives on patient experience.

trial registrationNCT04784325 (Mar 5, 2021).

Indexed as

Anti-Mullerian HormoneOvarian ReserveAdultCross-Over StudiesFemaleHumansPainProspective StudiesReproductionYoung AdultAnti-Mullerian HormoneAMHAnti-Müllerian hormoneBlood collectionHome deviceHome fertility testing

Identifiers

PMID36050723
PMCPMC9434544
OpenAlexW4294031785

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.