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A multicenter clinical trial study of preimplantation genetic haplotyping

A multicenter clinical trial study of preimplantation genetic haplotyping in chromosomally balanced translocation carriers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015863
Enrollment
Unknown
Registered
2018-04-25
Start date
2018-06-01
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

chromosomally balanced translocation?inversion

Interventions

Gold Standard:karyotype of amniotic fluid cells, cord blood or abortion tissue
Index test:PGH

Sponsors

Obstetrics and Gynecology Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) One of the couple carries a balanced chromosome translocation. Parents of the carriers need to be tested the peripheral blood karyotype at the same time to confirm the translocation as new or hereditary. If the parental sample cannot be obtained, a brother or sister who is also the translocation carrier is optional. If none of the above samples is available, a sample of unbalanced translocation embryos will be used for linkage analysis; 2) Inclusive patients may be those who have a new cycle or those who have completed an ovulation cycle and have normal diploid embryos after PGS testing (no transplantation or no pregnancy after transplantation). It is recommended that the number of blastocysts in the new cycle should be no less than 5, and no less than 2 normal blastocysts in the completed ovulation cycle; 3) If the patient's embryo does not meet the above requirements within one cycle, then a new cycle was optional to cumulate the number of embryos; 4) Embryos detected by PGH are obtained after ICSI.

Exclusion criteria

Exclusion criteria: 1) History of the following diseases: history of thyroid disease, history of adrenal gland disease, history of sexually transmitted diseases and mental disorders; 2) The following abnormalities of the uterus: uterine malformations (single angle uterus, double uterus), untreated mediastinal uterus, uterine adenomyoma, submucosal uterine fibroids, endometrial polyps; 3) Contraindications to assisted reproductive technology or diseases that have a clear impact on pregnancy: including poorly controlled type I, type 2 diabetes; undiagnosed liver or kidney disease or hepatorenal insufficiency; severe anemia History of deep venous thrombosis, pulmonary embolism, cardiovascular and cerebrovascular diseases, uncontrolled high blood pressure, heart disease, suspicious or unequivocal cancer and undiagnosed vaginal bleeding.

Design outcomes

Primary

MeasureTime frame
Karyotype of fetus amniotic fluid;

Secondary

MeasureTime frame
Karyotype of umbilical cord blood;Karyotype of fetus villus;

Countries

China

Contacts

Public ContactCongjian Xu

Obstetrics and Gynecology Hospital of Fudan University

xucj@hotmail.com+86 13651796353

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026