Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

Subfertility Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04538560
• Other study ID #: P2020002
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: January 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 36 Years to 42 Years

Eligibility

Inclusion Criteria:

• patients between their 36th and 42st birthdays;
• absence of any type of genetic abnormality in the patient's personal and family history;
• M? 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;
• M? oocytes =10 or = 1;
• three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles.

Related Conditions & MeSH terms

• Aneuploidy
• Infertility
• Subfertility

Intervention

Procedure:
• polar 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.

Locations

Country	Name	City	State
China	Reproductive and Genetic Hospital of Citic-xiangya	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative live birth rate		22 months
Secondary	abortion rate		22 months
Secondary	time required to obtained a live birth		22 months