Objectives: To determine pregnancy rate after comprehensive chromosome screening (CCS) using PGD NGS in frozen embryo transfer cycles after blastocyst’s trophoectoderm biopsy. Design: Prospective study. Setting: A private centers for reproductive medicine. Material and methods: 40 patients who will decide to undergo PGD on 24 chromosomes on blastocystes with vitrification and frozen embryo transfer will be included in the study as a investigated group. A control group was adjusted according to anti-Müllerian hormone level (AMH) and antral follicle count (AFC). This group included 34 cases in whom a fresh cycle transfer was postponed for several reasons: progesterone > 2.0 ng / ml on the day of hCG administration (n = 16); endometrial thickness <6 mm on the day of hCG administration (n = 9); and a risk of ovarian hyperstimulation syndrome (OHSS) (n = 9) with qualification for FET cycle; this group involved frozen blastocysts without PGD transfer. Intervention(s): Choice of the embryos for transfer based on the PGD NGS results. Main Outcome Measure(s): Clinical pregnancy rate (PR) per embryo transfer will be our primary outcome. Secondary outcome will be the implantation rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062318202N1
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
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of next generation sequencing (NGS) preimplantation genetic diagnostics (PGD) on pregnancy rate of frozen blastocyst embryo transfer.
Public title
The impact of next generation sequencing (NGS) preimplantation genetic diagnostics (PGD) on pregnancy rate of frozen blastocyst embryo transfer.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Incusion: 1. Patients undergoing assisted reproductive treatment with intracytoplasmic sperm injection and frozen blastocyst embryotransfer in Invicta Fertility and Reproductive Centre s. z o.o. in time frame from 08.2014 to 09.2014
Exclusion: 1. Blastocysts in stages 2CC, 3CC, 4CC, and 5CC did not qualify for biopsy.
2.Patients in whom no normal embryo was available
Age
From 33 years old to 42 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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