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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687567
Recruitment Status : Completed
First Posted : September 27, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

Study Description
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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.


Condition or disease Intervention/treatment
Thalassemia,Embryonic Development,Reproductive Sterility and Infertility Procedure: Preimplantation genetic diagnosis

Study Design
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Study Type : Observational
Actual Enrollment : 737 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
HBA
alpha-Thalassemia
 Procedure: Preimplantation genetic diagnosis
HBB
beta-Thalassemia
 Procedure: Preimplantation genetic diagnosis


Outcome Measures
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Primary Outcome Measures :
  1. Gardner grading of blastocysts [ Time Frame: embryo cultured in-vitro for 5-7 days ]
    development status of blastocysts


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One or both of infertility couples with thalassemia take PGD treatment.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687567


Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya
Investigators
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Principal Investigator: Liang Hu, MD,PHD Reproductive & Genetic Hospital of CITIC-Xiangya
More Information
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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03687567    
Other Study ID Numbers: KYXM-201804
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn