- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04644380
Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
Studieoversigt
Detaljeret beskrivelse
This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.
The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Primary Endpoint
• Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.
Secondary Endpoint
- Comfort of the INVOcell IVC and Retention Device
- Vaginal tissue reactions during the vaginal incubation
- Optical clarity and the ability to visualize the embryos after the incubation
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alabama
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Homewood, Alabama, Forenede Stater, 35209
- American Institute of Reproductive Medicine/IVF Alabama (AIRM)
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Have been informed about the study and have given their written consent.
- Patients 18 years to 42 years
- Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.
Exclusion Criteria:
- Inability to read and speak English fluently
- Identified vaginal infection
- Recent pelvic surgery based on clinical history and physical examination.
- History of toxic shock syndrome
- Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
- Inability to tolerate a speculum examination
- Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation.
- Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment Group
During an IVF/IVC cycle, participants will retain the INVOcell Culture Device with the Retention Device in the vaginal cavity for 5 days vaginal incubation
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Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Device Retention
Tidsramme: 5 days
|
The primary endpoint is INVOcell IVC retention with the Retention Device. The following will be assessed: Whether the INVOcell IVC stays in place (is retained within the vaginal cavity) while being used with the Retention Device during 5 days of continuous vaginal incubation. |
5 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Comfort
Tidsramme: 5 days
|
Comfort of the INVOcell IVC while worn with the Retention Device evaluated on a 10-oint Likert scale.
|
5 days
|
Vaginal tissue reactions
Tidsramme: 5 days
|
Vaginal tissue reactions during the vaginal incubation based on post removal and assessed by vaginal speculum examination performed to examine the vaginal walls speculum examination post removal vaginal examination.
|
5 days
|
Optical clarity
Tidsramme: 5 days
|
Optical clarity and the ability to visualize the embryos after the incubation of the INVOcell device.
|
5 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Karen Hammond, DNP, CRNP, American Institute of Reproductive Medicine/IVD Alabama (AIRM)
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CP-018
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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