Evidence map›Paper›PMID 32000803›Full record

ArticleReproductive health2020

Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial.

Werner M Neuhausser, Denis A Vaughan, Denny Sakkas, Michele R Hacker, Tom Toth, Alan Penzias

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

Article in Reproductive health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03764865 (Day 3 vs Day 5 Embryo Transfer for Patients With Low Embryo Numbers Going Through in Vitro Fertilization), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT03764865 nacompletednot on this mapstarted 2021, after this paper: background citation

Day 3 vs Day 5 Embryo Transfer for Patients With Low Embryo Numbers Going Through in Vitro Fertilization (PILOT STUDY)

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2021 to 2022Enrolled10ConditionsInfertilityArmsday 3 uterine transfer, day 5 uterine transfer
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

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  16. The Mare: A Pertinent Model for Human Assisted Reproductive Technologies?Animals : an open access journal from MDPI · 2021
    Review
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

6 authors at 3 institutions in 1 country.

Werner M NeuhausserDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA. wneuhaus@bidmc.harvard.edu.ORCID http://orcid.org/0000-0002-5092-2658
Denis A VaughanDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Denny SakkasBoston IVF, Waltham, MA, USA.
Michele R HackerDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Tom TothDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Alan PenziasDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Beth Israel Deaconess Medical Center · USBoston IVF · USBroad Institute · US

Funding

Harvard Catalyst UL 1TR002541
6 · The paper itself

Abstract

backgroundWith improvements in in vitro culture techniques there has been a steady shift in practice to transfer embryos at the blastocyst stage (post fertilization day (p.f.d.) 5-7), when embryos reach the endometrial cavity during natural conception. For patients with > 5 zygotes on day 1 of embryo development, fresh blastocyst embryo transfer (ET) increases live birth rates when compared to cleavage stage (p.f.d. 3) transfer. In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage. However, there is a dearth of randomized controlled trial (RCT) data demonstrating improved live birth rates per cycle for cleavage vs blastocyst stage ET in this subgroup of patients. The hypothesis of the PRECiSE (PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer) trial is that blastocyst ET is not inferior to cleavage stage ET with regard to live birth rates per retrieval in poorer prognosis patients. The adoption of routine blastocyst culture for all patients would result in higher rates of single embryo transfers (SET), reduced incidence of multiple pregnancies and simplified laboratory protocols, thereby reducing costs. METHODS/

designMulticenter, non-inferiority randomized controlled trial (RCT) comparing blastocyst to cleavage stage embryo transfer in poorer prognosis patients with ≤5 zygotes on day 1 after fertilization. The primary outcome is live birth per retrieval. Secondary outcomes include: time to pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage and multiple pregnancy rate (per retrieval). This trial will enroll 658 women with ≤5 zygotes on day 1 at 6 IVF centers over the course of 22 months. DISCUSSION: If the hypothesis is proven true, the data from this trial may facilitate the adoption of uniform blastocyst culture in all IVF patients.

trial registrationClinicalTrials.gov Identifier: NCT03764865. Registered 5 December 2019, Protocol issue date: 4 December 2018, Original.

Indexed as

Abortion, SpontaneousBlastocystEmbryo TransferFertilization in VitroLive BirthAdolescentAdultBirth RateBostonEquivalence Trials as TopicFemaleHumansMulticenter Studies as TopicPregnancyPregnancy OutcomePregnancy RateBlastocyst transferCleavage-stage transferIn vitro fertilizationNon-inferiority randomized controlled trial

Identifiers

PMID32000803
PMCPMC6993366
OpenAlexW3011656610

What OpenQuestion holds

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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.