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Status unknownNCT04538560Updated Jan 11, 2022

Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

An interventional study of polar body biopsy in Subfertility, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Status unknown at 1 site in China. Open to female participants aged 36 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
36 Years to 42 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Subfertility

Keywords

  • poor ovarian respond，
  • advanced age
  • Preimplantation Genetic Testing
03

Who can participate

Ages eligible
36 Years to 42 Years
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Polar body biopsy group

    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.

    Procedure: polar body biopsy

  • No intervention
    Control group

    The control group will undergo routine culture and the transfer priority is determined according to the morphological score only.

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.

05

What researchers measure

Primary outcomes

  1. Cumulative live birth rate

    Time frame: 22 months

Secondary outcomes

  1. abortion rate

    Time frame: 22 months

  2. time required to obtained a live birth

    Time frame: 22 months

06

Study locations

1 of 1 sites recruiting
  • Reproductive and Genetic Hospital of Citic-xiangya
    Changsha, Hunan 410000, China
    • xiaojuan Wang, Doc · Contact · 646829625@qq.com · +86-731-82355100
    • Ge Lin, PhD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT04538560
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Sep 4, 2020
Start date
Oct 20, 2020
Primary completion
Jan 30, 2022 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
Jan 11, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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