A Retrospective Study on the Effect of HBA or HBB Genetic... | NCT03687567

Studies
A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development

NCT03687567

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

737Actual

Phase

Not provided

Conditions

Thalassemia,Embryonic Development,Reproductive Sterility and Infertility

Interventions

Preimplantation genetic diagnosis

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

Dec 2021

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

Sep 1, 2013Actual

Primary Completion Date

Jul 31, 2018Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Sep 26, 2018

First Submission Date that Met QC Criteria

Sep 26, 2018

First Posted Date

Sep 27, 2018Actual

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 10, 2022

Last Update Posted Date

Jan 11, 2022Actual

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

Thalassemia is an anemia or pathological state caused by compounding absently or inadequately of one or more globin chains of hemoglobin due to the defects of the globin gene,and the carrying rate is high in southern China. Although there are many studies of Thalassemia, the relationship between the globin gene defects and the early embryo development has not been reported.

This study intends to carry out a retrospective analysis on the embryonic development of the patients with thalassemia assisted by PGD from January 1, 2011 to now in our hospital, to explore whether the HBA or HBB gene defects have a certain influence on the early embryo development, so as to accumulate certain data for reproductive health research.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

737Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HBA		alpha-Thalassemia	Procedure: Preimplantation genetic diagnosis
HBB		beta-Thalassemia	Procedure: Preimplantation genetic diagnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preimplantation genetic diagnosis	Procedure		HBA HBB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gardner grading of blastocysts	development status of blastocysts	embryo cultured in-vitro for 5-7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infertility couples with thalassemia(one or both )
infertility couples treat by PGD

Exclusion Criteria:

abortion of amplification for blastula biopsy
PGD without diagnostic results or with unclear diagnostic results
embryos with both HBA and HBB genetic defect

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

One or both of infertility couples with thalassemia take PGD treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liang Hu, MD,PHD	Reproductive & Genetic Hospital of CITIC-Xiangya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive & Genetic Hospital of CITIC-XIANGYA		Changsha	Hunan	410008	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013789	Thalassemia
D007246	Infertility

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided