Effect of Degranulation Needle With Different Diameters o... | NCT03810040

Studies
Effect of Degranulation Needle With Different Diameters on the Rate Good Embryo in IVF

NCT03810040

Sponsor

Tang-Du Hospital

Status

Unknown status

Last Update Posted

Jan 18, 2019Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Embryo

Interventions

140 microns denuding pipette
150 microns denuding pipette

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2019Estimated

Primary Completion Date

May 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Jul 5, 2018

First Submission Date that Met QC Criteria

Jan 17, 2019

First Posted Date

Jan 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2019

Last Update Posted Date

Jan 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Detailed Description

Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. The participants were divided into two group. Odd-numbered days the zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Odd-numbered days	Active Comparator	Once odd-numbered days the zytoges of IVF cycle were collected. The 140 microns denuding pipette was used.	Device: 140 microns denuding pipette
Even-numbered days	Experimental	Once even-numbered days the zytoges of IVF cycle were collected. The 150 microns denuding pipette was used.	Device: 150 microns denuding pipette

Interventions

Name	Type	Description	Arm Group Labels	Other Names
140 microns denuding pipette	Device	the degranulated needle size was 140 microns	Odd-numbered days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quality of embryo	embryo quality assessed by good embryo rate	one year

Secondary Outcomes

Measure	Description	Time Frame
clinical outcome - clinical prengancy rate	clinical prengancy rate	three years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

first cyele of IVF treatment

Exclusion Criteria:

oocyte number less than 4
oocyte number over than 25

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
wang ming	Contact	8613259809290		wangmingbio@snnu.edu.cn

Overall Officials

Name	Affiliation	Role
jin ni	Tang-Du Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tangdu Hospital		Xi'an	Shaanxi	710038	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided