Clinical trial NCT04856696: Clinical Application of Non-invasive PGT-A
Official title: Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Testing
Keywords: PGT
PGT-A
non-invasive PGT-A
embryo biopsy
spent media
cell free DNA
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: Sofiva Genomics Co., Ltd.
First posted: 2021-04-23
Enrollment: 22
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A.

Detailed description: Background Chromosome abnormality is a leading cause of implantation failure and miscarriage. Chromosome abnormality increases with age, resulting in reduced pregnancy rate. Nowadays, preimplantation genetic testing for aneuploidies (PGT-A) could be used for detection of aneuploidy. However, PGT-A needs embryo biopsy which is invasive and may cause embryo damage. It was found that cell free DNA could be isolated from culture media. The cell free DNA from culture media also could be used to detect embryo ploidy, called non-invasive PGT-A.

Objective The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A. Another aim of this study is to check the concordance rate between non-invasive PGT-A and PGT-A.

Methods The prospective cohort study will be performed at the reproductive medical center of Kaohsiung Veterans General Hospital, in Kaohsiung, Taiwan. Participants who plan to receive an IVF cycle and preimplantation genetic testing for aneuploidies will be enrolled in this study. The investigators will divide the participants into 3 groups: (1) combined non-invasive PGT-A and PGT-A; (2) PGT-A; (3) non-invasive PGT-A. Basal characteristics, infertility history, ovarian reserve and embryo development of the three groups will be recorded. The samples will be detected ploidy by using next generation sequencing (NGS). Then, the investigators will choose embryo to transfer according to the embryo ploidy and follow the pregnancy outcomes after embryo transfer.

Outcome

1. Concordance rate between non-invasive PGT-A and PGT-A
2. The relationship between morphological grade and ploidy of non-invasive PGT-A
3. IVF outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A

Eligibility criteria: Inclusion Criteria:

* Infertile women who undergo IVF with PGT
* BMI:18\~30 kg/m2

Exclusion Criteria:

* Primary ovarian insufficiency
* Congenital uterine anomaly
* Severe male infertility (azoospermia)
* One of the couples with chromosome abnormality
* Malignancy

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: through study completion, an average of 1.5 year
measure: Miscarriage rate
timeFrame: through study completion, an average of 1.5 year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kuan-Hao Tsui
role: STUDY_DIRECTOR
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