InfertilityNCT03001648
Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )
An observational study of Infertility and Preimplantation Genetic Screening, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
This is a single centre retrospective study in repeated implantation failure patients: < 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Preimplantation Genetic Screening
- What is being tested?
- PGS (Preimplantation Genetic Screening) with trophectoderm biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Dec 2016
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Repeated implantation failure patients: patients <39 years old that have received at least 4 day 3 good quality embryos or 2 good quality blastocists with no implantation.
Who may be able to join
- women < 39 years
- repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality blastocysts transferred without implantation
Who cannot join
- partner with severe male factor, or abnormal sperm Fluorescence in situ hybridization (FISH) analysis
- presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia, uncontrolled thyroid disfunction or autoimmune disease
Trial locations and contacts
1 site in 1 country.
Spain1 site
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, Barcelona, 08037
About this study
This is a single centre retrospective study in repeated implantation failure patients: < 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).
Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally. Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to standard IVF cycles.
- Conditions
- Infertility, Preimplantation Genetic Screening
- Being tested
- PGS (Preimplantation Genetic Screening) with trophectoderm biopsy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGS (Preimplantation Genetic Screening) with trophectoderm biopsyProcedure or surgery
PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH)
| Study group | Role | What they receive |
|---|---|---|
| PGS | Patients with RIF scheduled for PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridation (aCGH) underwent one or more stimulation cycles. If euploid blastocysts were available, patients underwent frozen embryo transfer/s. Receives: Procedure: PGS (Preimplantation Genetic Screening) with trophectoderm biopsy | |
| Standard IVF | Patients with RIF scheduled for standard IVF (In Vitro Fertilization) underwent a single stimulation cycle with the fresh embryo transfer and the subsequent frozen embryo transfers if there were surplus frozen embryos and the fresh embryo transfer was unsuccessful. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Measured: at 24 months of first embryo transfer
Secondary outcomes (3)
Clinical Pregnancy Rate
Measured: 6 weeks after embryo transfer
Implantation Rate
Measured: 6 weeks after embryo transfer
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 posted23 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Devesa, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001648
- Sponsor's protocol ID
- SMD-DEX-2016-02
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )
- ClinicalTrials.gov ID
- NCT03001648
- Acronym / sponsor ID
- SMD-DEX-2016-02
- Conditions
- Infertility, Preimplantation Genetic Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Dec 2016 (estimated)
- 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.
This is a single centre retrospective study in repeated implantation failure patients: < 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).
Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally. Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to standard IVF cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGS | – | Procedure: PGS (Preimplantation Genetic Screening) with trophectoderm biopsyPatients with RIF scheduled for PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridation (aCGH) underwent one or more stimulation cycles. If euploid blastocysts were available, patients underwent frozen embryo transfer/s. |
| Standard IVF | – | –Patients with RIF scheduled for standard IVF (In Vitro Fertilization) underwent a single stimulation cycle with the fresh embryo transfer and the subsequent frozen embryo transfers if there were surplus frozen embryos and the fresh embryo transfer was unsuccessful. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Repeated implantation failure patients: patients <39 years old that have received at least 4 day 3 good quality embryos or 2 good quality blastocists with no implantation.
Key inclusion criteria (2 listed)
- women < 39 years
- repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality blastocysts transferred without implantation
Key exclusion criteria (2 listed)
- partner with severe male factor, or abnormal sperm Fluorescence in situ hybridization (FISH) analysis
- presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia, uncontrolled thyroid disfunction or autoimmune disease
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 |
|---|---|---|
| PGS (Preimplantation Genetic Screening) with trophectoderm biopsyPGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH) | Procedure or surgery | PGS |
Primary outcome
Cumulative live birth rate
Time frame: at 24 months of first embryo transfer
3 secondary outcomes
Clinical Pregnancy Rate
Time frame: 6 weeks after embryo transfer
Implantation Rate
Time frame: 6 weeks after embryo transfer
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 23 Dec 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Preimplantation Genetic Screening, run by Fundacion Dexeus at 1 site in Spain.
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 2 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 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cumulative live birth rate (time frame: at 24 months of first 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 23 Dec 2016.