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Clinical Trials/NCT04538560
NCT04538560
Unknown
Not Applicable

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)

Reproductive & Genetic Hospital of CITIC-Xiangya1 site in 1 country20 target enrollmentOctober 20, 2020
ConditionsSubfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subfertility
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Enrollment
20
Locations
1
Primary Endpoint
Cumulative live birth rate
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2020
End Date
April 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Cumulative live birth rate

Time Frame: 22 months

Secondary Outcomes

  • abortion rate(22 months)
  • time required to obtained a live birth(22 months)

Study Sites (1)

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