Chromosomal AbnormalitiesNCT00795795
Preimplantation Genetic Screening in Women of Advanced Maternal Age
A study testing Preimplantation Genetic Screening and IVF without PGS in people with Chromosomal Abnormalities, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. Read more about this study
- Who is it for?
- Ages 38 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Chromosomal Abnormalities
- What is being tested?
- Preimplantation Genetic Screening and IVF without PGS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2008to Dec 2011
- Phase
- Interventional
- 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 38 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female Patients over 37 years old, attending a fertility clinic
Who cannot join
- Azoospermic partners
- Female patients with uterine malformations
- number of retreived oocytes below 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA)
An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients.
In our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits.
Read more
Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:
- Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed
- Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.
- Conditions
- Chromosomal Abnormalities
- Being tested
- Preimplantation Genetic Screening, IVF without PGS
- Keywords
- Chromosomal abnormalities in preimplantation embryos
- Medical subject headings
- Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic ScreeningProcedure or surgery
Preimplantation Genetic Screening
IVF without PGSProcedure or surgery
IVF without PGS
| Study group | Role | What they receive |
|---|---|---|
| with PGS | Active comparator | IVF cycles with Preimplantation Genetic Screening (PGS) Receives: Procedure: Preimplantation Genetic Screening |
| Without PGS | Active comparator | IVF cycle without Preimplantation Genetic Screening Receives: Procedure: Preimplantation Genetic Screening; Procedure: IVF without PGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing implantation per embryo and per pacient
Measured: one month
Secondary outcomes (1)
Take home baby
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosomal AbnormalitiesStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795795
- Sponsor's protocol ID
- 0802-C-046-CR
- Status last verified
- Mar 2012
- First submitted
- 20 Nov 2008
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA)
- ClinicalTrials.gov ID
- NCT00795795
- Acronym / sponsor ID
- 0802-C-046-CR
- Conditions
- Chromosomal Abnormalities
- Keywords
- Chromosomal abnormalities in preimplantation embryos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Nov 2008 (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.
An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients.
In our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits.
Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:
- Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed
- Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with PGS | Active comparator | Procedure: Preimplantation Genetic ScreeningIVF cycles with Preimplantation Genetic Screening (PGS) |
| Without PGS | Active comparator | Procedure: Preimplantation Genetic Screening, Procedure: IVF without PGSIVF cycle without Preimplantation Genetic Screening |
Who may qualify
- Ages
- 38 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female Patients over 37 years old, attending a fertility clinic
Key exclusion criteria (3 listed)
- Azoospermic partners
- Female patients with uterine malformations
- number of retreived oocytes below 5
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 |
|---|---|---|
| Preimplantation Genetic ScreeningPreimplantation Genetic Screening | Procedure or surgery | Without PGS, with PGS |
| IVF without PGSIVF without PGS | Procedure or surgery | Without PGS |
Primary outcome
ongoing implantation per embryo and per pacient
Time frame: one month
1 secondary outcome
Take home baby
Time frame: 9 months
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 2 Apr 2012.
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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?
A study testing Preimplantation Genetic Screening and IVF without PGS in people with Chromosomal Abnormalities, run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 1 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 2 Apr 2012. 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?
ongoing implantation per embryo and per pacient (time frame: one month). 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 2 Apr 2012.