- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02467725
EnMotion, Embryo's Natural Motion (EnMotion)
3. april 2019 opdateret af: Reproductive Medicine Associates of New Jersey
EnMotion, Embryo's Natural Motion: The Impact of Dynamic Culture on the Development of Useable Blastocysts
The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo development and reproductive potential in comparison to static culture.
Studieoversigt
Detaljeret beskrivelse
The proposed research design is a prospective randomized control trial.
Patients with normal ovarian reserve, who would be expected to have reasonable outcomes after in vitro fertilization, will serve as the subjects.
Embryos from the same patient will be randomized to either static or dynamic culture.
They will then be cultured to the blastocyst stage of embryo development and biopsied for preimplantation genetic screening.
The best chromosomally normal embryo from each culture group will be selected and transferred to complete a double embryo transfer in a subsequent frozen embryo transfer cycle the following month.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Jersey
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Basking Ridge, New Jersey, Forenede Stater, 07920
- Reproductive Medicine Associates of New Jersey
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 42 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Infertile women seeking in vitro fertilization treatment with aneuploidy screening
- Patient is eligible for a two-embryo transfer in compliance with ASRM guidelines
- Patient able to undergo a frozen embryo transfer cycle the month following the vaginal oocyte retrieval procedure
- Maximum day 3 Follicle-stimulating hormone level (≤12 IU/L)
- Anti-mullerian hormone level ≥ 1.2g/mL, tested within previous year
- ≤1 prior failed IVF cycle
- Male partner with >100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
- Body Mass Index ≤ 32
- Antral Follicle Count ≥ 8
Exclusion Criteria:
- Diagnosis of endometrial insufficiency defined as a prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Use of oocyte donation
- Use of gestational carrier
- Medical contraindication to double embryo transfer
- Use of testicular aspiration or biopsy procedures to obtain sperm
- Presence of a hydrosalpinx that communicates with the endometrial cavity
- Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
- Single gene disorder requiring more detailed embryo genetic analysis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Dynamic Culture Platform
Embryos randomized to the dynamic arm will be placed on the NSSB-300 microvibration platform within the designated incubator.
The platform will vibrate at a strength setting of 4 for 5 seconds every 60 minutes.
The embryos will be placed on the platform at the two pronucleur stage of development and remain on the platform until the blastocyst stage of development at which time the embryos will be biopsied for preimplantation genetic screening and frozen.
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Patients will have their cohort of embryos split in half.
Half will be cultured in the dynamic platform and the other half cultured in static.
Andre navne:
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Ingen indgriben: Static Culture
The embryos randomized to the static or control arm of the study will be placed directly into the incubator and will not have any additional vibration, per routine care.
The embryos will be placed in the incubator at the two pronucleur stage of development and remain in the incubator until the blastocyst stage of development at which time the embryos will be biopsied for preimplantation genetic screening and frozen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Blastulation Rate
Tidsramme: 6 days post vaginal oocyte retrieval procedure
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the number of blastocysts will be counted
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6 days post vaginal oocyte retrieval procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Clinical Pregnancy Rate
Tidsramme: approximately 20-25 days post embryo transfer procedure
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documented intrauterine pregnancy
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approximately 20-25 days post embryo transfer procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Richard T Scott, MD, HCLD, Reproductive Medicine Associates of New Jersey
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. juni 2015
Primær færdiggørelse (Faktiske)
31. maj 2018
Studieafslutning (Faktiske)
15. oktober 2018
Datoer for studieregistrering
Først indsendt
3. juni 2015
Først indsendt, der opfyldte QC-kriterier
9. juni 2015
Først opslået (Skøn)
10. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RMA-2015-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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