Next Generation Sequencing Screening for Embryonic Ploidy Status

Infertility Clinical Trial

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Official title:

Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032264
• Other study ID #: RMA-2013-04
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: March 16, 2017
• Start date: December 2013
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy. All viable blastocysts will be biopsied and cryopreserved for future transfer. After the final embryo is cryopreserved, patients will be randomized to either the intervention group or the control group. Patients and doctors are blinded to the randomization until study completion. A Double Embryo Transfer (DET) will be performed with either screened or unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in cases where only one embryo is available for transfer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Patient undergoing IVF/CCS (no PGD banking)

• Patient meets ASRM guidelines for Double Embryo Transfer (DET)

• Donor Sperm OK

• AMH = 1.2

• FSH = 12

• BAFC =12

• Max 1 prior failed IVF cycle for patients 35-45 years old

• Patient <35 years old MUST have 1 prior failed IVF cycle

Exclusion Criteria:

• Chronic endometrial insufficiency

• Use of oocyte donor or gestational carriers

• Medical contraindications to Double Embryo Transfer (DET)

• Male Factor (<100,000 sperm or surgical sperm)

• Communicating hydrosalpinx (on HSG)

• Single gene disorders or sex selection

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Comprehensive Chromosome Screening
On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.
• Morphologically Best
Patients in this arm of the study will not receive CCS in selection of their embryo for transfer. The best looking embryo (morphology) will be transferred

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of next generation sequencing on the embryos produced from IVF on implantation rates	To evaluate the benefits, if any, of using next generation sequencing based Comprehensive Chromosome Screening (CCS) in the selection of embryos for transfer during clinical IVF cycles	2 years
Secondary	Delivery Rates		2 years

External Links

•   Reproductive Medicine Associates of New Jersey