Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

NCT ID: NCT04538560

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Subfertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

polar body biopsy

Intervention Type PROCEDURE

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

36 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Reproductive and Genetic Hospital of Citic-xiangya

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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xiaojuan Wang, Doc

Role: primary

+86-731-82355100

Other Identifiers

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P2020002

Identifier Type: -

Identifier Source: org_study_id

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