Status:

COMPLETED

Embryo Selection by Noninvasive Preimplantation Genetic Test

Lead Sponsor:

Peking University Third Hospital

Collaborating Sponsors:

Jinling Hospital, China

Reproductive Medical Center of Hebei Maternity Hospital

Conditions:

Infertility

Chromosome Abnormality

Eligibility:

FEMALE

35-42 years

Phase:

NA

Brief Summary

The objective of this study is to explore whether non-invasive chromosome screening (NICS) can be used as an effective indicator for embryos selection besides morphology through a multicenter randomiz...

Detailed Description

Chromosomal abnormalities commonly exist in early human embryos, and often cause embryo implantation failure and pregnancy loss in in-vitro fertilization (IVF) treatments. Preimplantation genetic test...

Eligibility Criteria

Inclusion

  • Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle
  • Female age: 35 - 42 years old
  • Women receiving controlled ovarian hyperstimulation treatment (including ultra-long protocol、long-protocol 、short protocol treatment with GnRH agonist and GnRH antagonist treatment protocol); and the number of oocytes ≥6; The female BMI is from 18 to 30kg/m2.
  • Culture embryos to blastocyst stage and all the blastocysts will be single cryopreserved.
  • Single frozen-thawed blastocyst Transferred for the first time
  • The number of blastocysts ≥2, morphology grade (above 4BC/4CB)
  • Written informed consent

Exclusion

  • One of couples with IVF or ICSI contraindications(such as poorly controlled type I or type II diabetes; liver disease or dysfunction; kidney disease or renal function abnormality; significant anemia; history of deep venous thrombosis, pulmonary embolus; history of cerebrovascular accident; uncontrolled hypertension or diagnosed heart disease; history of cervical, endometrial or breast cancer; undiagnosed vaginal bleeding.)
  • PGT cycles
  • Women who have pathologies or malformations that affect the pregnancy outcome: genital malformations, untreated hydrosalpinx, untreated uterine infections, intramural myomas \> 4cm , benign tumor of pelvic and abdominal cavity\> 4cm, intimal thickness\<8mm, pituitary tumors and malignant tumors of various tissues and organs during the patient's participation in the study
  • Untreated hyperprolactinemia, thyroid disease, adrenal disease
  • Women with endometrial polyps that were not treated before embryo transfer

Key Trial Info

Start Date :

April 16 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 6 2024

Estimated Enrollment :

1152 Patients enrolled

Trial Details

Trial ID

NCT04339166

Start Date

April 16 2020

End Date

August 6 2024

Last Update

December 11 2025

Active Locations (13)

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Page 1 of 4 (13 locations)

1

The First Affiliated Hospital,Sun Yat-sen University

Guanzhou, Guangdong, China

2

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

3

Hebei Maternity and Reproductive hospital

Shijiazhuang, Hebei, China

4

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China