PGT-A/SR study
- Conditions
- Patients of InfertilityD007247
- Registration Number
- JPRN-jRCT1052220197
- Lead Sponsor
- Handa Mika
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 383
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ongoing pregnancy rate at 12 gestational weeks to 13 gestational weeks in the study population underwent embryo transfer.
- Secondary Outcome Measures
Name Time Method 1) Early miscarriage rate at examination from 12 gestational weeks to 13 gestational weeks in the embryo transfer group<br>2) Implantation rate (including biochemical pregnancies) in the embryo transfer group<br>3) Clinical pregnancy rate per implantation (including biochemical abortions) in the embryo transfer group<br>4) Pregnancy loss rate per implantation (including biochemical abortions) in the embryo transfer group