Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

Preimplantation Genetic Testing for Aneuploidy by Next-generation Sequencing of Polar Bodies in Advanced Maternal Age With Poor Ovarian Responders: a Randomized Clinical Trial (Preliminary Experiments)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04538560

Enrollment

Registered

2020-09-04

Start date

2020-10-20

Completion date

2022-04-30

Last updated

2022-01-11

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

Conditions

Subfertility

Keywords

poor ovarian respond，, advanced age, Preimplantation Genetic Testing

Brief summary

This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.

Interventions

PROCEDUREpolar body biopsy

Undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

36 Years to 42 Years

Healthy volunteers

Yes

Inclusion criteria

* patients between their 36th and 42st birthdays; * absence of any type of genetic abnormality in the patient's personal and family history; * MⅡ oocytes: 2-9 .

Exclusion criteria

* treatment involving donor oocytes; * any type of genetic abnormality or family history of genetic abnormality in subject or partner; * with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy; * poor embryo quality in previous cycles; * Preimplantation genetic testing for aneuploidy(PGT-A) cycles; * MⅡ oocytes ≥10 or ≤ 1; * three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles.

Design outcomes

Primary

Measure	Time frame
Cumulative live birth rate	22 months

Secondary

Measure	Time frame
abortion rate	22 months
time required to obtained a live birth	22 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026