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A Comparative Study on the Diagnostic Performance of Multiplex PCR and Next-Generation Sequencing for niPGT-M for Thalassemias, Using Trophectoderm Biopsy as the Gold Standard

A Comparative Study on the Diagnostic Performance of Multiplex PCR and Next-Generation Sequencing for niPGT-M for Thalassemias, Using Trophectoderm Biopsy as the Gold Standard

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260311003
Enrollment
68
Registered
2026-03-11
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Couples, who are carriers of or affected by a thalassemia disease either alpha or beta thalassemia Thalassemia

Interventions

Spent culture medium collection: collected 2-2.5 mcL of spent culture medium from each embryo drop in both groups. Group I: SCM contained BF, Group II: SCM only,Spent culture medium collection: colle
Experimental Procedure/Surgery,Experimental Procedure/Surgery
non invasive PGT-M (SCM contained BF),non invasive PGT-M (SCM only)

Sponsors

Chiang Mai University Funding
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Couples, undergoing assisted reproductive technologies treatment at Chiang Mai Fertility Center or Chiang Mai IVF Polyclinic, who are carriers of or affected by a thalassemia disease either alpha or beta thalassemia, and have requested PGT- M for their embryos.

Exclusion criteria

Exclusion criteria: 1. Couples who decline to undergo PGT-M will be excluded. 2. Couples who refuse to adhere to the study protocol will be excluded.

Design outcomes

Primary

MeasureTime frame
concordance rate between TE biopsy and niPGT-M at 3 months after end of the intervention concordance rate

Secondary

MeasureTime frame
Sensitivity at 3 months after end of the intervention Sensitivity ,specificity at 3 months after end of the intervention specificity

Countries

Thailand

Contacts

Public ContactRasrawee Chantrasiri

Chiang Mai University

rcbeautie@gmail.com0641955666

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026