Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

January 9, 2022 updated by: Reproductive & Genetic Hospital of CITIC-Xiangya

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Reproductive and Genetic hospital of CITIC-xiangya
        • Principal Investigator:
          • Ge Lin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

34 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
No Intervention: Control group
The control group will undergo routine culture and the transfer priority is determined according to the morphological score only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative live birth rate
Time Frame: 22 months
22 months

Secondary Outcome Measures

Outcome Measure
Time Frame
abortion rate
Time Frame: 22 months
22 months
time required to obtained a live birth
Time Frame: 22 months
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

August 30, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2020002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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