Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

Not Applicable

• Conditions: Subfertility
• Interventions: Procedure: polar body biopsy

• Registration Number: NCT04538560
• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-30
• Study First Submitted QC: 2020-08-30
• Study First Posted: 2020-09-04
• Study Start: 2020-10-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-09
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-01-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polar body biopsy group	polar body biopsy	The study group will 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.

Primary Outcome Measures

Name	Time	Method
Cumulative live birth rate	22 months

Secondary Outcome Measures

Name	Time	Method
abortion rate	22 months
time required to obtained a live birth	22 months

Trial Locations

Locations (1)

Reproductive and Genetic Hospital of Citic-xiangya; 🇨🇳 Changsha, Hunan, China