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NCT06722313
Optimized PGT-M Strategy for Patients With No Proband
NA trial testing Gametes (sperm or second polar bodies, MI eggs) or arrested embryos were reserved for identification of a proband in De Novo Mutation in 5 participants. Enrolling by invitation.
31 December 2024
Quick facts
| Lead sponsor | ShangHai Ji Ai Genetics & IVF Institute |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 5 |
| Start date | 1 January 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Gametes (sperm or second polar bodies, MI eggs) or arrested embryos were reserved for identification of a proband
Conditions studied
- De Novo Mutation — all drugs for De Novo Mutation →
- Preimplantation Genetic Testing — all drugs for Preimplantation Genetic Testing →
- Without Proband — all drugs for Without Proband →
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
Who can join
Eligibility, any sex, with De Novo Mutation or Preimplantation Genetic Testing. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The clinical practice of PGT-M for monogenetic disease usually adopted a double-checking strategy, which detect the mutation by Sanger sequencing and meantime construct haplotypes using the DNA sample of the proband so as to avoid the risks of misdiagnosis due to recombination and allele drop out (ADO). When there is no affected parent or offspring to serve as the proband, embryo carriers identified through direct mutation detection can be preferentially taken as probands for subsequent linkage analysis. In cases where none of the embryos are detected as mutant carrier, single sperm or the second polar body (PB2) can be complementally collected in the work-up of haplotype establishment. Our study aims to develop an optimized strategy of haplotype construction using gametes or arrested embryos for PGT-M in pedigrees with single gene diseases and no proband in the setting of difficult cases, which takes into account the expected number of oocytes acquired and the gonadal mosaicism.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06722313 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ShangHai Ji Ai Genetics & IVF Institute
- Last refreshed: 9 December 2024
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