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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04538560
Other study ID # P2020002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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