Thalassemia,Embryonic Development,Reproductive Sterility and InfertilityNCT03687567
A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development
An observational study of Thalassemia,Embryonic Development,Reproductive Sterility and Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thalassemia,Embryonic Development,Reproductive Sterility and Infertility
- What is being tested?
- Preimplantation genetic diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 737 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2013to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: One or both of infertility couples with thalassemia take PGD treatment.
Who may be able to join
- infertility couples with thalassemia(one or both )
- infertility couples treat by PGD
Who cannot join
- abortion of amplification for blastula biopsy
- PGD without diagnostic results or with unclear diagnostic results
- embryos with both HBA and HBB genetic defect
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008
About this study
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.
- Being tested
- Preimplantation genetic diagnosis
- Medical subject headings
- Thalassemia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation genetic diagnosisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HBA | alpha-Thalassemia Receives: Procedure: Preimplantation genetic diagnosis | |
| HBB | beta-Thalassemia Receives: Procedure: Preimplantation genetic diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gardner grading of blastocysts
development status of blastocysts
Measured: embryo cultured in-vitro for 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Sep 2013
- Primary completion31 Jul 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia,Embryonic Development,Reproductive Sterility and InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang Hu, MD,PHD, Principal investigator, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687567
- Sponsor's protocol ID
- KYXM-201804
- Status last verified
- Dec 2021
- First submitted
- 26 Sep 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Effect of HBA or HBB Genetic Defects on Early Embryonic Development
- ClinicalTrials.gov ID
- NCT03687567
- Acronym / sponsor ID
- KYXM-201804
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBA | – | Procedure: Preimplantation genetic diagnosisalpha-Thalassemia |
| HBB | – | Procedure: Preimplantation genetic diagnosisbeta-Thalassemia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One or both of infertility couples with thalassemia take PGD treatment.
Key inclusion criteria (2 listed)
- infertility couples with thalassemia(one or both )
- infertility couples treat by PGD
Key exclusion criteria (3 listed)
- abortion of amplification for blastula biopsy
- PGD without diagnostic results or with unclear diagnostic results
- embryos with both HBA and HBB genetic defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preimplantation genetic diagnosis | Procedure or surgery | HBA, HBB |
Primary outcome
Gardner grading of blastocysts
Time frame: embryo cultured in-vitro for 5-7 days
development status of blastocysts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Hu, MD,PHD principal investigator
Reproductive & Genetic Hospital of CITIC-Xiangya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia,Embryonic Development,Reproductive Sterility and Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gardner grading of blastocysts (time frame: embryo cultured in-vitro for 5-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.