Embryo AneuploidiesNCT01571076
Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor
A study testing PGS and Prolonged culture in people with Embryo Aneuploidies and Implantation Rates, run by Igenomix at 1 site in Spain.
Trial summary
Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Embryo Aneuploidies, Implantation Rates, Infertility
- What is being tested?
- PGS and Prolonged culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Feb 2015
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women's Age: 38- 41 years old (both included)
- Men's Age: 18-60 years old (both included)
- Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid)
- Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified)
- Quality of semen: ≥ 5 millions spermatozoids/ml
Who cannot join
- Number of Oocytes metaphase II (MII): <5 oocytes
- Number of Oocytes obtained: >20
- Estradiol on the day of human chorionic gonadotrophin (hCG) >3000 pgr/ml administration.
- Progesterone on the day of hCG >1,5 pmol/l administration
- ≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination)
- Any un corrected alteration in a previous study.
- Other indications of (Preimplantation Genetic Diagnosis.Screening) PGD-S, such as monogenic illnesses, translocations, repeated implantation failure, repeated miscarriages, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective and Randomized Study of the Use of Comparative Genomic Hybridization (CGH) Arrays to Study Embryo Aneuploidies in Female Advanced Age and Male Factor In Vitro Fertilization (IVF) Patients.
Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis.
This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).
Read the detailed description
The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility\&Sterility 2017).
The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).
- Conditions
- Embryo Aneuploidies, Implantation Rates, Infertility
- Being tested
- PGS, Prolonged culture
- Keywords
- PGS, CGH, Aneuploidy, Advanced maternal age, Male factor
- Medical subject headings
- Infertility, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGSGenetic
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
PGSGenetic
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
Prolonged cultureOther
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
Prolonged cultureOther
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
| Study group | Role | What they receive |
|---|---|---|
| Group B - Severe Male Factor | Experimental | PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) Receives: Other: Prolonged culture |
| Group B - Advanced Age | Experimental | PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) Receives: Other: Prolonged culture |
| Group A - Advanced Age | Active comparator | Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group Receives: Genetic: PGS |
| Group A - Severe Male Factor | Active comparator | Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group. Receives: Genetic: PGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Implantation and Pregnancy Rate
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 posted4 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embryo AneuploidiesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Carlos Simon, MDPhD, Principal investigator, DirectorCarmen Rubio, PhD, Study chair, Igenomix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571076
- Sponsor's protocol ID
- 1112-C-091-CR
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2012
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11.
PubMed 25599824
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Study of the Use of Comparative Genomic Hybridization (CGH) Arrays to Study Embryo Aneuploidies in Female Advanced Age and Male Factor In Vitro Fertilization (IVF) Patients.
- ClinicalTrials.gov ID
- NCT01571076
- Acronym / sponsor ID
- 1112-C-091-CR
- Conditions
- Embryo Aneuploidies, Implantation Rates, Infertility
- Keywords
- PGS, CGH, Aneuploidy, Advanced maternal age, Male factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Apr 2012 (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.
Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis.
This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).
Detailed description
The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility\&Sterility 2017).
The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group B - Severe Male Factor | Experimental | Other: Prolonged culturePGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) |
| Group B - Advanced Age | Experimental | Other: Prolonged culturePGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst) |
| Group A - Advanced Age | Active comparator | Genetic: PGSProlonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group |
| Group A - Severe Male Factor | Active comparator | Genetic: PGSProlonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women's Age: 38- 41 years old (both included)
- Men's Age: 18-60 years old (both included)
- Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid)
- Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified)
- Quality of semen: ≥ 5 millions spermatozoids/ml
Key exclusion criteria (7 listed)
- Number of Oocytes metaphase II (MII): <5 oocytes
- Number of Oocytes obtained: >20
- Estradiol on the day of human chorionic gonadotrophin (hCG) >3000 pgr/ml administration.
- Progesterone on the day of hCG >1,5 pmol/l administration
- ≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination)
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 |
|---|---|---|
| PGSPreimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts. | Genetic | Group A - Severe Male Factor |
| PGSPreimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts. | Genetic | Group A - Advanced Age |
| Prolonged cultureThe embryos will be in prolonged culture and on going embryos transferred on Day 5 . | Other | Group B - Advanced Age |
| Prolonged cultureProlonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts. | Other | Group B - Severe Male Factor |
Primary outcome
Ongoing Implantation and Pregnancy Rate
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 19 Jan 2021.
- Derived from this study: PubMed 25599824Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11.
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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.
Carlos Simon, MDPhD principal investigator
Director
Carmen Rubio, PhD study chair
Igenomix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PGS and Prolonged culture in people with Embryo Aneuploidies and Implantation Rates, run by Igenomix 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 5 inclusion and 7 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 19 Jan 2021. 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 and Pregnancy Rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571076, which also lists 1 linked publication.
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 19 Jan 2021.