Back to resultsPreimplantation Genetic Testing for Aneuploidy of Polar Bodies
Primary Purpose
Subfertility
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
polar body biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility focused on measuring poor ovarian respond，, advanced age, Preimplantation Genetic Testing
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.
Sites / Locations
- Reproductive and Genetic Hospital of Citic-xiangyaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Polar body biopsy group
Control group
Arm Description
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.
The control group will undergo routine culture and the transfer priority is determined according to the morphological score only.
Outcomes
Primary Outcome Measures
Cumulative live birth rate
Secondary Outcome Measures
abortion rate
time required to obtained a live birth
Full Information
NCT ID
NCT04538560
First Posted
August 30, 2020
Last Updated
January 9, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
1. Study Identification
Unique Protocol Identification Number
NCT04538560
Brief Title
Preimplantation Genetic Testing for Aneuploidy of Polar Bodies
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
poor ovarian respond，, advanced age, Preimplantation Genetic Testing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polar body biopsy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will undergo routine culture and the transfer priority is determined according to the morphological score only.
Intervention Type
Procedure
Intervention Name(s)
polar body biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative live birth rate
Time Frame
22 months
Secondary Outcome Measure Information:
Title
abortion rate
Time Frame
22 months
Title
time required to obtained a live birth
Time Frame
22 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Reproductive and Genetic Hospital of Citic-xiangya
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaojuan Wang, Doc
Phone
+86-731-82355100
Email
646829625@qq.com
First Name & Middle Initial & Last Name & Degree
Ge Lin, PhD
12. IPD Sharing Statement
Learn more about this trial
Preimplantation Genetic Testing for Aneuploidy of Polar Bodies
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