In Vitro FertilizationNCT00593671
Preimplantation Genetic Screening in Women Over 35 Year
A study testing Preimplantation genetic screening after embryo biopsy in people with In Vitro Fertilization, run by KU Leuven at 1 site in Belgium.
Trial summary
In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to… Read more about this study
- Who is it for?
- Ages 35 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Preimplantation genetic screening after embryo biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2002to Jan 2007
- 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 35 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.
Who cannot join
- Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.
In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.
In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.
- Conditions
- In Vitro Fertilization
- Being tested
- Preimplantation genetic screening after embryo biopsy
- Keywords
- aneuploidies in 7 chromosomes increased with advanced maternal age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation genetic screening after embryo biopsyProcedure or surgery
Preimplantation genetic screening after embryo biopsy
| Study group | Role | What they receive |
|---|---|---|
| PGS group | Active comparator | Not described Receives: Procedure: Preimplantation genetic screening after embryo biopsy |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical implantation rate per embryo transferred
Measured: end of study
Secondary outcomes (1)
Pregnancy rate per transfer
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJun 2002
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Thomas M D'Hooghe, MD, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593671
- Sponsor's protocol ID
- sdbroc0
- Status last verified
- Jan 2008
- First submitted
- 4 Jan 2008
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.
- ClinicalTrials.gov ID
- NCT00593671
- Acronym / sponsor ID
- sdbroc0
- Conditions
- In Vitro Fertilization
- Keywords
- aneuploidies in 7 chromosomes increased with advanced maternal age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Jan 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.
In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.
In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGS group | Active comparator | Procedure: Preimplantation genetic screening after embryo biopsy |
| control group | No intervention | – |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.
Key exclusion criteria (1 listed)
- Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.
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 screening after embryo biopsyPreimplantation genetic screening after embryo biopsy | Procedure or surgery | PGS group |
Primary outcome
Clinical implantation rate per embryo transferred
Time frame: end of study
1 secondary outcome
Pregnancy rate per transfer
Time frame: end of study
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 15 Jan 2008.
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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.
Thomas M D'Hooghe, MD study director
UZ Leuven
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 after embryo biopsy in people with In Vitro Fertilization, run by KU Leuven at 1 site in Belgium.
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 1 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 15 Jan 2008. 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 Belgium. 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?
Clinical implantation rate per embryo transferred (time frame: end of study). 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 15 Jan 2008.