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

Thalassemia,Embryonic Development,Reproductive Sterility and Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687567
• Other study ID #: KYXM-201804
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Thalassemia
• Thalassemia,Embryonic Development,Reproductive Sterility and Infertility

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