InfertilityBIOPSNCT03173885
Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening
A study testing Preimplantation Genetic Screening in people with Infertility and Preimplantation Genetic Screening, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to… Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility, Preimplantation Genetic Screening
- What is being tested?
- Preimplantation Genetic Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 18 May 2017to 5 Feb 2020
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- at least 2 blastocysts suitable for biopsy on day 5 of embryo development remaining after fresh transfer
- willing and able to give informed consent
- infertility as an indication for IVF/ICSI
- first or second IVF/ICSI cycle
- patients willing to accept single embryo transfer
- BMI range 18 to 35 kg/m2
Who cannot join
- any type of genetic abnormality or family history of genetic abnormality in subject or partner
- any other non-study related preimplantation genetic testing
- three or more clinical miscarriages (recurrent pregnancy loss, RPL)
- recurrent implantation failure (RIF): no positive β-hCG after transfer (fresh IVF/ICSI cycle or frozen) with no less than 6 cleavage stage embryos or no less than 4 blastocysts, all of good quality and of appropriate developmental stage
- severe endometriosis
- abnormal uterine cavity
- cycles requiring surgical sperm recovery procedures, total asthenozoospermia and/or globozoospermia
- treatment involving use of donor oocytes or use of gestational carrier
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ghent University Hospital - Department of Reproductive Medicine
Ghent, 9000
About this study
Official title: An RCT Evaluating the Implantation Potential of Vitrified Embryos Screened by Next Generation Sequencing Following Trophectoderm Biopsy, Versus Vitrified Unscreened Embryos in Good Prognosis Patients Undergoing IVF
This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).
- Conditions
- Infertility, Preimplantation Genetic Screening
- Being tested
- Preimplantation Genetic Screening
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic ScreeningDiagnostic test
- laser assisted hatching
- trophectoderm biopsy
- next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| PGS (genetic screening) | Experimental | Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment Receives: Diagnostic Test: Preimplantation Genetic Screening |
| no PGS (no genetic screening) | No intervention | Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Rate of clinical pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after transfer of embryo in PGS arm versus in no PGS arm.
Measured: At 7 - 8 gestational weeks
Secondary outcomes (4)
Biochemical pregnancy
Rate of biochemical pregnancy (a pregnancy diagnosed only by either serum or urine β-hCG, and the serial results decrease to negative; no ultrasonic visualisation of one or more gestational sacs) after transfer of embryo in PGS arm versus in no PGS arm.
Measured: At 7 -8 gestational weeks
Clinical miscarriage
Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm.
Measured: At 7 - 16 gestational weeks
Live birth
Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm.
Measured: At delivery
Aneuploidy
Rate of aneuploid versus rate of euploid embryos in PGS arm.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start18 May 2017
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Why it stopped: Due to the slow recruitment of patients
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 InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT (randomized controlled trial)
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra De Sutter, M.D; PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173885
- Sponsor's protocol ID
- B670201629937
- Other IDs
- 2016/1235
- Acronym
- BIOPS
- Status last verified
- Sep 2024
- First submitted
- 19 May 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
PubMed 32898291
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Evaluating the Implantation Potential of Vitrified Embryos Screened by Next Generation Sequencing Following Trophectoderm Biopsy, Versus Vitrified Unscreened Embryos in Good Prognosis Patients Undergoing IVF
- ClinicalTrials.gov ID
- NCT03173885
- Acronym / sponsor ID
- BIOPS / B670201629937
- Conditions
- Infertility, Preimplantation Genetic Screening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the slow recruitment of patients
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 2 Jun 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.
This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT (randomized controlled trial)
| Arm | Type | Receives |
|---|---|---|
| PGS (genetic screening) | Experimental | Diagnostic Test: Preimplantation Genetic ScreeningIntent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment |
| no PGS (no genetic screening) | No intervention | –Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- at least 2 blastocysts suitable for biopsy on day 5 of embryo development remaining after fresh transfer
- willing and able to give informed consent
- infertility as an indication for IVF/ICSI
- first or second IVF/ICSI cycle
- patients willing to accept single embryo transfer
Key exclusion criteria (8 listed)
- any type of genetic abnormality or family history of genetic abnormality in subject or partner
- any other non-study related preimplantation genetic testing
- three or more clinical miscarriages (recurrent pregnancy loss, RPL)
- recurrent implantation failure (RIF): no positive β-hCG after transfer (fresh IVF/ICSI cycle or frozen) with no less than 6 cleavage stage embryos or no less than 4 blastocysts, all of good quality and of appropriate developmental stage
- severe endometriosis
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* laser assisted hatching * trophectoderm biopsy * next generation sequencing | Diagnostic test | PGS (genetic screening) |
Primary outcome
Clinical pregnancy
Time frame: At 7 - 8 gestational weeks
Rate of clinical pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after transfer of embryo in PGS arm versus in no PGS arm.
4 secondary outcomes
Biochemical pregnancy
Time frame: At 7 -8 gestational weeks
Clinical miscarriage
Time frame: At 7 - 16 gestational weeks
Live birth
Time frame: At delivery
Aneuploidy
Time frame: At delivery
Results and safety
The study was stopped early (reason given: Due to the slow recruitment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 32898291Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
- 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.
Petra De Sutter, M.D; PhD principal investigator
University Hospital, Ghent
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 in people with Infertility and Preimplantation Genetic Screening, run by University Hospital, Ghent 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 was stopped early (reason given: Due to the slow recruitment of patients). Results are not available in the source record.
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 pregnancy (time frame: At 7 - 8 gestational weeks). 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 NCT03173885, 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 Sep 2024.