Embryo Selection by Noninvasive Preimplantation Genetic Test

Infertility Clinical Trial

— ESNi-PGT  

Official title:

A Multicenter Clinical Study on Embryo Selection by Using the Ploidy of Cell Free DNA in Embryo Culture Medium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04339166
• Other study ID #: ESNi-PGT
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Peking University Third Hospital
• Contact: Jie Qiao
• Phone: 010-82265080
• Email: jie.qiao[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 randomized controlled trial, by comparing the differences of live birth rate, pregnancy rate and miscarriage rate between the two groups of embryo selection by "NICS+ morphology" and embryo selection only by "morphology" in IVF cycle.

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 testing for aneuploidies (PGT-A) by comprehensive chromosome screening (CCS) has been widely applied in IVF practices to select embryos with normal ploidy. Although multiple clinical trials have demonstrated improved clinical outcomes with PGT-A, it's in controversial for whether PGT-A is truly worthwhile to be offered to all IVF patients. One of the main concerns is that it involves an embryo biopsy procedure, which is invasive and the long-term safety issue of the embryo biopsy remains to be fully investigated.

In recent years, researchers have found that the spent medium of embryo culture contains trace amount of cell-free DNA, which may reflect the ploidy of the embryo. The non-invasive chromosome screening (NICS) approach utilizing spent culture medium samples has been evaluated in studies. However, the clinical value of NICS as a new effective indicator to evaluate embryo competence so far has not been justified by randomized clinical trials.

The main purpose of this project is to verify whether NICS can be used as a new effective indicator for evaluating embryo developmental potential through multi-center, randomized clinical trials

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1148
• Est. completion date: August 31, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

Inclusion Criteria:

1. Infertile couples receiving IVF- ICSI procedure for assisted reproduction cycle

2. Female age: 35 - 42 years old

3. 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.

4. Culture embryos to blastocyst stage and all the blastocysts will be single cryopreserved.

5. Single frozen-thawed blastocyst Transferred for the first time

6. The number of blastocysts =2, morphology grade (above 4BC/4CB)

7. Written informed consent

Exclusion Criteria:

1. 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.)

2. PGT cycles

3. 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

4. Untreated hyperprolactinemia, thyroid disease, adrenal disease

5. Women with endometrial polyps that were not treated before embryo transfer

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Abnormality
• Chromosome Disorders
• Infertility

Intervention

Diagnostic Test:
• Non-invasive chromosome screening(NICS)
NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	The First Medical Center of Chinese People's Liberation Army General Hospital	Beijing
China	Reproductive & Genetic Hospital of Citic-Xiangya	Changsha	Hunan
China	West China Second Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital,Sun Yat-sen University	Guanzhou	Guangdong
China	Jinling Hospital,Nanjing University,School Medicine	Nanjing	Jiangsu
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	Hebei Maternity and Reproductive hospital	Shijiazhuang	Hebei
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Northwest women's and children's hospital	Xi'an
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (14)

Lead Sponsor

Collaborator

Peking University Third Hospital

First Affiliated Hospital, Sun Yat-Sen University, Jinling Hospital,Nanjing University,School Medicine, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Peking University Shenzhen Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Reproductive Medical Center of Hebei Maternity Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shengjing Hospital, The First Medical Center of Chinese People's Liberation Army General Hospital, The Second Hospital of Hebei Medical University, Third Affiliated Hospital of Zhengzhou University, West China Second University Hospital, Yikon Genomics Company, Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Number of women with ongoing pregnancies after the first transfer/ number of women randomized to the specific group	12 weeks after the first embryo transfer
Secondary	Clinical pregnancy rate	Number of women with clinical pregnancies after the first transfer / number of women randomized to the specific group	7 weeks after the first embryo transfer
Secondary	Miscarriage rate	Number of pregnancy losses / number of clinical pregnancies after the first transfer.	28 weeks of after the first embryo transfer
Secondary	Live birth rate	Number of women with live births after the first transfer / number of women randomized to the specific group.	within 2 weeks after live birth