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PGT-A/SR study

Analysis of Preimplantation Genetic Testing for aneuploidy/structural rearrangement (PGT-A/SR)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052220197
Enrollment
383
Registered
2023-03-17
Start date
2023-04-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Patients of Infertility

Interventions

At a facility approved by the Japan Society of Obstetrics and Gynecology, oocyte retrieval is performed on couples who wish to undergo PGT-A after obtaining their informed consent. Takara Bio Inc. per

Sponsors

Handa Mika
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Infertile couples undergoing embryo transfer for which IVF or ICSI can be performed as an insured procedure, who wish to undergo PGT-A, and who meet the following selection criteria (1) to (3) and do not meet the exclusion criteria. (1) Patients with a history of repeated IVF or ICSI/embryo transfer (ART) failures (repeated ART failures) Selection Criteria (1) Patients with a history of repeated IVF or ICSI/EMT failures. (2) Able to obtain written consent to participate in the clinical research with his/her partner. (3) If the research subject and his/her partner are both at least 18 years of age. 2) Persons with a history of repeated miscarriages (habitual miscarriage (including repeated miscarriages)) Selection Criteria (1) Subjects with a history of repeated miscarriages and stillbirths (2) Persons who are able to obtain written consent for participation in clinical research together with their partners. 3) Both the research subject and his/her partner are at least 18 years of age. 3) Chromosomal structural abnormalities (e.g., balanced chromosome translocations) in either the research subject or his/her partner are confirmed (chromosomal structural abnormalities). Selection criteria (1) Chromosome structural abnormalities (t(11;22)(q23;q11) for balanced reciprocal translocations, rob(13;14) for Robertsonian translocations, etc.) are confirmed in the research subject or his/her partner. (2) Persons who are able to obtain written consent to participate in clinical research together with their partners. 3) Both the research subject and his/her partner are over 18 years old.

Exclusion criteria

Exclusion criteria: 1) Inappropriate ART patients with severe complications such as severe heart failure or other complications that are considered to have a significant potential to cause significant damage to maternal health during pregnancy and delivery 2) Patients who have undergone PGT-A/SR at least once in this study 3) Persons who have underwent embryotransfer in which has been performed PGT-A/SR in this study at least once 4) Other persons deemed inappropriate by the principal investigator or a physician who is a research participant.

Design outcomes

Primary

MeasureTime frame
The ongoing pregnancy rate at 12 gestational weeks to 13 gestational weeks in the study population underwent embryo transfer.

Secondary

MeasureTime frame
1) Early miscarriage rate at examination from 12 gestational weeks to 13 gestational weeks in the embryo transfer group 2) Implantation rate (including biochemical pregnancies) in the embryo transfer group 3) Clinical pregnancy rate per implantation (including biochemical abortions) in the embryo transfer group 4) Pregnancy loss rate per implantation (including biochemical abortions) in the embryo transfer group

Contacts

Public ContactMika Handa

Osaka university

pgt-a-senshin@gyne.med.osaka-u.ac.jp+81-668793356

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026