The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
1 other identifier
observational
383
0 countries
N/A
Brief Summary
Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedFebruary 24, 2017
February 1, 2017
2.2 years
February 16, 2017
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing clinical pregnancy rate
Clinical pregnancy confirmed by ultrasound
20 weeks after embryo transfer
Secondary Outcomes (3)
Implantation Rate
6 weeks after embryo transfer
Number of available euploid blastocysts per cycle
Up to 15 days after embryo biopsy
Miscarriage Rate
Until 20 weeks after embryo transfer
Study Arms (2)
Cleavage stage biopsy group
Patients undergoing a PGS cycle with single blastomere biopsy on day 3 and analysis using comparative genomic hybridation bacterial artificial chromosome (BAC) arrays (aCGH) If euploid blastocysts were available, patients underwent fresh blastocyst transfer on day 5.
Trophectoderm biopsy group
Patients undergoing a PGS cycle with blastocyst biopsy on day 5-7 and analysis using comparative genomic hybridation bacterial artificial chromosome (BAC) arrays (aCGH). If euploid blastocysts were available, patients underwent frozen-thawed blastocyst transfer.
Interventions
* intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF * Time lapse embryo culture * Cleavage stage biopsy * aCGH analysis * Fresh euploid embryo transfer
* ICSI-IVF * Time lapse embryo culture * Day 3 zona pellucida opening * Trophectoderm biopsy * aCGH analysis * Frozen-thawed euploid embryo transfer
Eligibility Criteria
Patients undergoing a PGS cycle with own gametes for any of the following indications: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies.
You may qualify if:
- Own gametes
- PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies
You may not qualify if:
- PGS cycles with gamete donation
- Altered karyotypes
- Combined Preimplantation genetic diagnosis (PGD)+PGS cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion Dexeuslead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 24, 2017
Study Start
January 1, 2014
Primary Completion
February 28, 2016
Study Completion
January 1, 2017
Last Updated
February 24, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share