NCT03687567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
737

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

4.9 years

First QC Date

September 26, 2018

Last Update Submit

January 10, 2022

Conditions

Thalassemia,Embryonic Development,Reproductive Sterility and Infertility

Outcome Measures

Primary Outcomes (1)

  • Gardner grading of blastocysts

    development status of blastocysts

    embryo cultured in-vitro for 5-7 days

Study Arms (2)

HBA

alpha-Thalassemia

Procedure: Preimplantation genetic diagnosis

HBB

beta-Thalassemia

Procedure: Preimplantation genetic diagnosis

Interventions

Preimplantation genetic diagnosisPROCEDURE
HBAHBB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

ThalassemiaInfertility

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenital DiseasesUrogenital Diseases

Study Officials

  • Liang Hu, MD,PHD

    Reproductive & Genetic Hospital of CITIC-Xiangya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 27, 2018

Study Start

September 1, 2013

Primary Completion

July 31, 2018

Study Completion

December 31, 2020

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations

CN(1)