Availability of Poor Quality Embryos | NCT01715545

Studies
Availability of Poor Quality Embryos

NCT01715545

Sponsor

The Second Affiliated Hospital of Kunming Medical University

Status

Completed

Last Update Posted

Oct 29, 2012Estimated

Enrollment

481Actual

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

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

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Oct 25, 2012

First Posted Date

Oct 29, 2012Estimated

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

Oct 25, 2012

Last Update Posted Date

Oct 29, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yang Jie, The Second Affiliated Hospital of Kunming Medical University, The Second Affiliated Hospital of Kunming Medical UniversityPrincipal Investigator

Lead Sponsor

The Second Affiliated Hospital of Kunming Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos

Detailed Description

Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. The viability of these embryos are tested in frozen-thawed transfer.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

481Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
day-3 poor quality embryos
developmental stage		day3 poor quality embryos day4 morular day-5/6 blastocyst

Interventions

Not provided

Measure	Description	Time Frame
pregnancy rate		5 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unfertile women

Exclusion Criteria:

women older than 40 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

unfertile women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jie Yang	The Second Affiliated Hospital of Kunming Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Kunming Medical University		Kunming	Yunnan	650101	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	(1) Lu LI, Xiao-xi SUN, Jun-ling CHEN, et al. Analysis of Factors Influencing Pregnancy Rate in Frozen-thawed Embryo Transfer. Journal of Reproduction and Contraception (2004) 15 (4):239-244

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases