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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03687567
Other study ID # KYXM-201804
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2013
Est. completion date December 31, 2020

Study information

Verified date December 2021
Source Reproductive & Genetic Hospital of CITIC-Xiangya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 737
Est. completion date December 31, 2020
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Preimplantation genetic diagnosis


Locations

Country Name City State
China Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gardner grading of blastocysts development status of blastocysts embryo cultured in-vitro for 5-7 days