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

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ClinicalTrials.gov Identifier: NCT03687567
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

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

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Study Type : Observational
Estimated 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
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

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



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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Liang Hu, MD,PHD 86-0731-82355100-8478 lianghu7@gmail.com

Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA Recruiting
Changsha, Hunan, China, 410008
Contact: Xiaojuan Wang, doctor    073182355100    646829625@qq.com   
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

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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03687567     History of Changes
Other Study ID Numbers: KYXM-201804
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
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
Genital Diseases, Male
Genital Diseases, Female
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn