Overview

This trial is active, not recruiting.

Condition infertility
Treatments comprehensive chromosome screening, morphologically best
Sponsor Reproductive Medicine Associates of New Jersey
Collaborator Ferring Pharmaceuticals
Start date December 2013
End date October 2016
Trial size 250 participants
Trial identifier NCT02032264, RMA-2013-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Trophectoderm biopsy will be performed on all blastocysts and CCS via next generation sequencing screening performed on biopsy samples. Patients will proceed with a single or double embryo transfer of the one or two morphologically best euploid embryos
comprehensive chromosome screening PGD
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.
(Placebo Comparator)
The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.
morphologically best Unscreened
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

Primary Outcomes

Measure
Impact of next generation sequencing on the embryos produced from IVF on implantation rates
time frame: 2 years

Secondary Outcomes

Measure
Delivery Rates
time frame: 2 years

Eligibility Criteria

Female participants from 18 years up to 42 years old.

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

Additional Information

Official title Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
Principal investigator Richard T Scott, M.D., HCLD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Reproductive Medicine Associates of New Jersey.