臨床研究等提出・公開システム

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

PGT-A/SR study

Handa Mika

Osaka university hospital

2-15, Yamadaoka, Suita-shi, Osaka, Japan

tadashi@gyne.med.osaka-u.ac.jp

Handa Mika

Osaka university

2-2, Yamadaoka, Suita-shi, Osaka, Japan

+81-668793356

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

Recruiting

Mar. 17, 2023

Interventional

single arm study

open(masking not used)

historical control

single assignment

screening

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.

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.

Female

Patients of Infertility

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. performs the PGT-A /SR. Based on the obtained information on chromosome euploidy or aneuploidy, a determination is made as to whether the embryos are A to D embryos. Among these, the subjects to whom embryos determined to be A or B were transferred will be examined.

Translated with www.DeepL.com/Translator (free version)

D007247

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

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

+81-6-6210-8296

Feb. 14, 2023

No

none