NCT04538560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

August 30, 2020

Last Update Submit

January 9, 2022

Conditions

Subfertility

Keywords

poor ovarian respond，advanced agePreimplantation Genetic Testing

Outcome Measures

Primary Outcomes (1)

  • Cumulative live birth rate

    22 months

Secondary Outcomes (2)

  • abortion rate

    22 months

  • time required to obtained a live birth

    22 months

Study Arms (2)

Polar body biopsy group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

polar body biopsyPROCEDURE

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.

Polar body biopsy group

Eligibility Criteria

Age36 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive and Genetic Hospital of Citic-xiangya

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2020

First Posted

September 4, 2020

Study Start

October 20, 2020

Primary Completion

January 30, 2022

Study Completion

April 30, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CN(1)