Routine use of next generation sequencing (NGS) for preimplantation genetic diagnostics (PGD) of blastomeres obtained from embryos on day 3 in fresh IVF cycles.
Objective: To determine the usefulness of semiconductor-based next generation sequencing (NGS) for cleavage-stage preimplantation genetic diagnosis (PGD) of aneuploidy.
Design: Prospective non randomized study.
Setting: A private centers for reproductive medicine.
Patient(s): 28 patients will undergo day-3 embryo biopsy with PGD and fresh cycle transfer. Additionally, 106 patients, match according to age, anti-müllerian hormone (AMH) levels, antral follicles count (AFC) and infertility duration will be selected to serve as controls.
Intervention(s): Choice of the embryos for transfer will be based on the PGD NGS results.
Main Outcome Measure(s): Clinical pregnancy rate (PR) per embryo transfer as primary outcome. Secondary outcome will be the implantation rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070118202N2
Registration date:2014-07-10, 1393/04/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-10, 1393/04/19
Registrant information
Name
Judyta Zabielska
Name of organization / entity
Invicta Sp.z o.o.
Country
Poland
Phone
0048 516 829 691
Email address
zabielska@gumed.edu.pl
Recruitment status
Recruitment complete
Funding source
Funded by Invicta s.z o.o.
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Routine use of next generation sequencing (NGS) for preimplantation genetic diagnostics (PGD) of blastomeres obtained from embryos on day 3 in fresh IVF cycles.
Public title
Routine use of next generation sequencing (NGS) for preimplantation genetic diagnostics (PGD) of blastomeres obtained from embryos on day 3 in fresh IVF cycles.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Incusion:
1. Patients undergoing in vitro fertilization in Invicta Fertility and Reproductive Centre s. z o.o. in time frame from 08.2014 to 01.2015
Exclusion:
1. Patients who did not received embryo transfer in first cycle
2. Lack of data/results according to 5 verifications (that means 6-8 week after embryo transfer)
Age
From 31 years old to 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej