Preimplantation Genetic Testing for Aneuploidy of Polar Bodies

Study Overview
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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.

Official Title
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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)

Conditions
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Subfertility

Intervention / Treatment
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* Procedure: polar body biopsy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polar body biopsy group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>The control group will undergo routine culture and the transfer priority is determined according to the morphological score only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative live birth rate |  | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abortion rate |  | 22 months | 
| time required to obtained a live birth |  | 22 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor ovarian respond，, advanced age, Preimplantation Genetic Testing