The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03062969

Enrollment

383

Registered

2017-02-24

Start date

2014-01-01

Completion date

2017-01-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Preimplantation Genetic Screening

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.

Detailed description

The investigators have recently introduced this new approach and a frozen-thawed policy of euploid blastocysts is routinely performed. This is a single centre retrospective study in patients undergoing a PGS cycle. The aim of the study is to assess the results obtained in a PGS programme after the implementation of a new biopsy timing and transfer policy. Results obtained in PGS cycles with blastocyst biopsy and frozen-thawed embryo transfer were analysed in comparison to cycles with cleavage stage biopsy and fresh blastocyst transfer.

Interventions

PROCEDURECleavage stage biopsy group

* intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF * Time lapse embryo culture * Cleavage stage biopsy * aCGH analysis * Fresh euploid embryo transfer

PROCEDURETrophectoderm biopsy group

* ICSI-IVF * Time lapse embryo culture * Day 3 zona pellucida opening * Trophectoderm biopsy * aCGH analysis * Frozen-thawed euploid embryo transfer

Study design

Observational model

CASE_CROSSOVER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* Own gametes * PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies

Exclusion criteria

* PGS cycles with gamete donation * Altered karyotypes * Combined Preimplantation genetic diagnosis (PGD)+PGS cycles

Design outcomes

Primary

Measure	Time frame	Description
Ongoing clinical pregnancy rate	20 weeks after embryo transfer	Clinical pregnancy confirmed by ultrasound

Secondary

Measure	Time frame	Description
Implantation Rate	6 weeks after embryo transfer	Embryos implanted confirmed by ultrasound
Number of available euploid blastocysts per cycle	Up to 15 days after embryo biopsy	Transferable or vitrified euploid blastocysts
Miscarriage Rate	Until 20 weeks after embryo transfer	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026