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CompletedNCT03687567Updated Jan 11, 2022

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

An observational study in Thalassemia,Embryonic Development,Reproductive Sterility and Infertility, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
737
Sex
All
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Study 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.

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Conditions studied

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

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 737 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
737 participants (actual)
Patient registry
No

Groups and cohorts

  • HBA

    alpha-Thalassemia

    Procedure: Preimplantation genetic diagnosis

  • HBB

    beta-Thalassemia

    Procedure: Preimplantation genetic diagnosis

Interventions

  • ProcedurePreimplantation genetic diagnosis
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What researchers measure

Primary outcomes

  1. Gardner grading of blastocysts

    development status of blastocysts

    Time frame: embryo cultured in-vitro for 5-7 days

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Study locations

1 site
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan 410008, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03687567
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Sep 27, 2018
Start date
Sep 1, 2013
Primary completion
Jul 31, 2018
Completion
Dec 31, 2020
Last update
Jan 11, 2022

Study contacts

Liang Hu, MD,PHD
principal investigator · Reproductive & Genetic Hospital of CITIC-Xiangya

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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