Clinical trial NCT02032264: Next Generation Sequencing Screening for Embryonic Ploidy Status
Official title: Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Next generation sequencing
Embryonic aneuploidy
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2014-01-10
Enrollment: 309
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Impact of next generation sequencing on the embryos produced from IVF on implantation rates
timeFrame: 2 years
Secondary outcomes:
measure: Delivery Rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, M.D., HCLD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
citation: Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.