InfertilityNCT03062969
The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
An observational study of Infertility and Preimplantation Genetic Screening, run by Fundacion Dexeus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Preimplantation Genetic Screening
- What is being tested?
- Cleavage stage biopsy group and Trophectoderm biopsy group
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 383 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Own gametes
- PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies
Who cannot join
- PGS cycles with gamete donation
- Altered karyotypes
- Combined Preimplantation genetic diagnosis (PGD)+PGS cycles
About this study
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.
Read the 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.
- Conditions
- Infertility, Preimplantation Genetic Screening
- Being tested
- Cleavage stage biopsy group, Trophectoderm biopsy group
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleavage stage biopsy groupProcedure or surgery
- intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF
- Time lapse embryo culture
- Cleavage stage biopsy
- aCGH analysis
- Fresh euploid embryo transfer
Trophectoderm biopsy groupProcedure or surgery
- ICSI-IVF
- Time lapse embryo culture
- Day 3 zona pellucida opening
- Trophectoderm biopsy
- aCGH analysis
- Frozen-thawed euploid embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cleavage stage biopsy group | |
| 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. Receives: Procedure: Trophectoderm biopsy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing clinical pregnancy rate
Clinical pregnancy confirmed by ultrasound
Measured: 20 weeks after embryo transfer
Secondary outcomes (3)
Implantation Rate
Embryos implanted confirmed by ultrasound
Measured: 6 weeks after embryo transfer
Number of available euploid blastocysts per cycle
Transferable or vitrified euploid blastocysts
Measured: Up to 15 days after embryo biopsy
Miscarriage Rate
Measured: Until 20 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Jan 2014
- Primary completion28 Feb 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lluc Coll Lujan, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062969
- Sponsor's protocol ID
- FDS-PGS-01
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
- ClinicalTrials.gov ID
- NCT03062969
- Acronym / sponsor ID
- FDS-PGS-01
- Conditions
- Infertility, Preimplantation Genetic Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleavage stage biopsy group | – | Procedure: Cleavage stage biopsy groupPatients 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 | – | Procedure: Trophectoderm biopsy groupPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Own gametes
- PGS for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies
Key exclusion criteria (3 listed)
- PGS cycles with gamete donation
- Altered karyotypes
- Combined Preimplantation genetic diagnosis (PGD)+PGS cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleavage stage biopsy group* intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF * Time lapse embryo culture * Cleavage stage biopsy * aCGH analysis * Fresh euploid embryo transfer | Procedure or surgery | Cleavage stage biopsy group |
| Trophectoderm biopsy group* ICSI-IVF * Time lapse embryo culture * Day 3 zona pellucida opening * Trophectoderm biopsy * aCGH analysis * Frozen-thawed euploid embryo transfer | Procedure or surgery | Trophectoderm biopsy group |
Primary outcome
Ongoing clinical pregnancy rate
Time frame: 20 weeks after embryo transfer
Clinical pregnancy confirmed by ultrasound
3 secondary outcomes
Implantation Rate
Time frame: 6 weeks after embryo transfer
Number of available euploid blastocysts per cycle
Time frame: Up to 15 days after embryo biopsy
Miscarriage Rate
Time frame: Until 20 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Preimplantation Genetic Screening, run by Fundacion Dexeus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing clinical pregnancy rate (time frame: 20 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.