Clinical PregnancyNCT04744844
DNA Amplification in Blastocoel Fluid
A study testing blastocoel fluid biopsy in people with Clinical Pregnancy and Embryo Implantation, run by Antalya IVF at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Although innovative procedural changes in frozen embryo transfer (FET) cycles have increased the implantation rate of blastocysts transferred significantly, blastocyst selection remains a significant limiting factor in implantation outcomes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pregnancy, Embryo Implantation
- What is being tested?
- blastocoel fluid biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 31 Jan 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with female age 18≤35 years on the day of consultation (with the clinician projecting female age to be ≤35 on the day of oocyte retrieval).
- Patients who provide informed consent to participate in the trial and for the use of their anonymized data in research.
- Patients with ≤2 previous IVF treatments.
- Patients predicted to have single blastocyst transfers.
Who cannot join
- Patients with female age >35 years on the day of consultation.
- Female patients with insulin-dependent diabetes or non-insulin-dependent diabetes mellitus and female patients with gastrointestinal, cardiovascular, pulmonary, liver or kidney disease.
- Female patients with any contraindications or allergies to the drugs used in routine freeze-all-IVF.
- Patients undergoing conventional PGT-A (aneuploidy) or PGT-M (monogenic disorders)
- Patients with less than 5 2-PN zygotes on day 1 of embryo development will be excluded from randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Absence of DNA Amplification in Blastocoel Fluid Enhance Conventional Blastocyst Selection and IVF Outcome?
Introduction: Although innovative procedural changes in frozen embryo transfer (FET) cycles have increased the implantation rate of blastocysts transferred significantly, blastocyst selection remains a significant limiting factor in implantation outcomes. To improve implantation rates requires conventional microscopic blastocyst morphology scoring/selection technique to be replaced by an enhanced blastocyst selection technique or for the conventional morphology selection technique to be strengthened by novel supplementary selection techniques. Blastocoel fluid biopsy with DNA amplification is a minimally invasive (mi) technique that may supplement a blastocyst morphology score variables with a genetic variable.
Objective: In the present randomized controlled trial (RCT), DNA amplification in blastocoel fluid biopsies (BF-biopsy) will be investigated as a supplementary measure to select blastocysts for transfer in conjunction with blastocyst morphology scores. The objective will be to develop a minimally invasive blastocyst selection technique, which will improve selection and increase clinical implantations, while not increasing costs.
Read more
Materials and Methods: A single IVF centre double-blind randomised controlled trial, with patients recruited having female age 18 to 35 years from infertile patients presenting for freeze-all-IVF treatment. Enrolled patients (N = 500) with ≥five 2PN zygotes after ICSI will be randomised (1:1) to the two arms of the trial (i.e., test and control arm). In the test arm, 3 blastocysts will undergo blastocoel fluid biopsy (BF-biopsy) and whole-genomic amplification. Single blastocysts with no DNA amplification will be transferred in FETs of the test arm and single top-scoring blastocysts will be transferred in FETs of the control arm. The primary outcome measure of the trial will be clinical implantation (i.e., gestational sac with fetal heartbeat).
Results: The clinical implantation outcomes of FETs in which score-selected single blastocyst with no DNA amplification and score-selected single blastocysts were transferred will be compared.
Read the detailed description
Introduction The goal of assisted reproductive technology (ART) is the delivery of a healthy singleton, with the treatment strategy in IVF having the best chance being the transfer of the single most viable embryo from a patient's embryo cohort. Embryo selection, therefore, is paramount to the success of this goal. The microscopic assessment and scoring of embryo morphology was developed as an embryo selection technique in the early years of IVF (Veeck, 1991) and has ever since remained the most widely practised embryo selection technique. However, the technique's limited ability to maximise embryo implantation rates has for long been lamented and, therefore, more enhanced embryo selection techniques have for long been sought. Time-lapse monitoring and scoring (Paulson et al., 2018) and euploid embryo transfer using PGT-A (preimplantation genetic testing for aneuploidy; Gleicher et al., 2017) are recent innovations that have become contenders to replace conventional microscopic assessment and scoring of embryo morphology. An advantage of PGT-A is its independence of embryo development and morphological feature assessments, as euploid blastocysts implant at the same rate irrespective of blastocyst morphology score (Capalbo et al., 2014). Moreover, besides PGT-A's technical and biological limitations, the costs of implementation PGT-A as an embryo selection technique may be regarded prohibitive by many.
In the evolution of PGT in human IVF, PGT has progressed from PGT-v1 to PGT-v2 based on the adverse outcomes of biopsying 1-2 blastomeres from cleavage-stage embryos (PGT-v1) and the improvement in blastocyst development conditions. The evidence suggested that PGT-v.1 posed a significant risk to embryo viability, with no benefit resulting from the transfer of euploid embryos (Gleicher et al., 2017). The majority of studies have reported that PGT-v2, which requires the biopsying of 5-10 trophectoderm (TE) cells, poses no significant risk to the developmental potential (implantation viability) of biopsied blastocysts. However, recently there have been reports, suggesting that TE biopsy may not be completely free of risk (Gleicher et al., 2017, Ozgur et al., 2019). Currently, PGT-A faces four challenges preventing its routine use as a blastocyst selection technique; (1) the need for high technical expertise, (2) the invasiveness of TE biopsy, (3) the cost of the full technique, and (4) that TE biopsy is subject to sampling bias - a single TE biopsy of 5-10 cells may not accurately represent the ploidy of the whole blastocyst.
A spin-off of conventional PGT is the analysis of DNA in blastocoel fluid (BF). This phenomenon was first reported by Palini et al. (2013). The origin of the DNA in BF has been suggested to be the result of embryo euploidisation, i.e., the elimination of aneuploidy DNA or aneuploidic cells through regulatory processes such as apoptosis and or necrosis (Leaver and Wells, 2019). The practice of blastocyst collapse before vitrification (Mukaida et al., 2006, Iwayama et al., 2011) provides the opportunity to perform minimally invasive PGT-A (miPGT-A), i.e., the biopsying BF. In a study to investigate ploidy concordance between PGT-A with TE biopsy and PGT-A with BF biopsy, the authors found that the clinical pregnancy rate was 77% for blastocysts with no DNA amplification were transferred and 37% for blastocysts with DNA amplification (Magli et al., 2018). The mere accumulation of DNA in the BF, therefore, could be used as a supplementary measure to prioritise blastocysts for transfer. Implementing BF-biopsy and whole-genomic amplification (WGA) as a supplementary selection measure limits/reduces three of PGT-A's main challenges; (1) technical expertise, (2) invasiveness, and (3) costs.
In the present randomized controlled trial (RCT), the investigators will investigate DNA amplification in blastocyst fluid biopsies (BF-biopsy) as a supplementary selection technique to select blastocysts for transfer in conjunction with blastocyst morphology scores. The clinical implantation outcomes of FETs in which score-selected single blastocyst with no DNA amplification and score-selected single blastocysts were transferred will be compared.
- Conditions
- Clinical Pregnancy, Embryo Implantation
- Being tested
- blastocoel fluid biopsy
- Keywords
- DNA, amplification, blastocyst fluid, blastocyst selection, frozen embryo transfer, minimally invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blastocoel fluid biopsyProcedure or surgery
In the present study, blastocoel fluid biopsy (BF-biopsy) and collapse will be performed using a microinjection pipette similar to that used to perform ICSI. The pipette will be pushed gently through the zona pellucida and TE, and up to 90% of the BF will be aspirated.
| Study group | Role | What they receive |
|---|---|---|
| DNA-amplification selection | Experimental | In the experimental arm, all blastocysts will undergo routine morphological assessment, with the 3 top-scoring blastocysts undergoing blastocoel fluid biopsy (BF-biopsy) and whole-genomic amplification. A single blastocyst with no DNA amplification will be selected for transfer in a frozen embryo transfer cycle. Receives: Procedure: blastocoel fluid biopsy |
| Morfological-score selection | Active comparator | In the active comparator arm, all blastocysts will undergo routine morphological assessment. The (single) top-scoring blastocyst will be selected for transfer in a frozen embryo transfer cycle. Receives: Procedure: blastocoel fluid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical implantation
Clinical implantation will be defined as a cycle with an ultrasound confirmed normal gestational sac and heartbeat.
Measured: Transvaginal ultrasound examinations will be performed after 5 weeks of gestation
Secondary outcomes (2)
pregnancy
Pregnancy will be defined as a cycle with an arbitrary serum βHCG level of >30 mIU/mL
Measured: Blood serum pregnancy tests will be performed 9 days after blastocyst transfer
ongoing pregnancy
Ongoing pregnancy will be defined as a cycle with an ultrasound confirmed normal gestational sac and heartbeat.
Measured: Transvaginal ultrasound examinations will be performed after 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Jan 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Funding for the trial was cancelled by funding organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Clinical PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single IVF centre double-blind randomised controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Coetzee, Antalya IVF
- Investigators
- Kemal Ozgur, MD, Study director, Antalya IVFKevin Coetzee, PhD, Principal investigator, Antalya IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744844
- Sponsor's protocol ID
- BF 13.1.2021:51
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD plan sharing plan: The protocol will be published (word document) on the completion of registration on ClinicalTrials.gov The relevant clinical data will be published on journal acceptance of the study (excel spreadsheet)
Publications
Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26.
PubMed 24578475Iwayama H, Hochi S, Yamashita M. In vitro and in vivo viability of human blastocysts collapsed by laser pulse or osmotic shock prior to vitrification. J Assist Reprod Genet. 2011 Apr;28(4):355-61. doi: 10.1007/s10815-010-9522-4. Epub 2010 Dec 9.
PubMed 21152966Magli MC, Albanese C, Crippa A, Tabanelli C, Ferraretti AP, Gianaroli L. Deoxyribonucleic acid detection in blastocoelic fluid: a new predictor of embryo ploidy and viable pregnancy. Fertil Steril. 2019 Jan;111(1):77-85. doi: 10.1016/j.fertnstert.2018.09.016. Epub 2018 Dec 5.
PubMed 30528055Ozgur K, Berkkanoglu M, Bulut H, Yoruk GDA, Candurmaz NN, Coetzee K. Single best euploid versus single best unknown-ploidy blastocyst frozen embryo transfers: a randomized controlled trial. J Assist Reprod Genet. 2019 Apr;36(4):629-636. doi: 10.1007/s10815-018-01399-1. Epub 2019 Jan 7.
PubMed 30617927Palini S, Galluzzi L, De Stefani S, Bianchi M, Wells D, Magnani M, Bulletti C. Genomic DNA in human blastocoele fluid. Reprod Biomed Online. 2013 Jun;26(6):603-10. doi: 10.1016/j.rbmo.2013.02.012. Epub 2013 Mar 13.
PubMed 23557766Veeck LL: Atlas of the Human Oocytes and Early Conceptus. 1991, Vol. 2. Baltimore, Williams & Willkins Co.
Paulson RJ, Reichman DE, Zaninovic N, Goodman LR, Racowsky C. Time-lapse imaging: clearly useful to both laboratory personnel and patient outcomes versus just because we can doesn't mean we should. Fertil Steril. 2018 Apr;109(4):584-591. doi: 10.1016/j.fertnstert.2018.01.042. No abstract available.
PubMed 29653705Gleicher N, Metzger J, Croft G, Kushnir VA, Albertini DF, Barad DH. A single trophectoderm biopsy at blastocyst stage is mathematically unable to determine embryo ploidy accurately enough for clinical use. Reprod Biol Endocrinol. 2017 Apr 27;15(1):33. doi: 10.1186/s12958-017-0251-8.
PubMed 28449669Mukaida T, Oka C, Goto T, Takahashi K. Artificial shrinkage of blastocoeles using either a micro-needle or a laser pulse prior to the cooling steps of vitrification improves survival rate and pregnancy outcome of vitrified human blastocysts. Hum Reprod. 2006 Dec;21(12):3246-52. doi: 10.1093/humrep/del285. Epub 2006 Aug 26.
PubMed 16936299
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Absence of DNA Amplification in Blastocoel Fluid Enhance Conventional Blastocyst Selection and IVF Outcome?
- ClinicalTrials.gov ID
- NCT04744844
- Acronym / sponsor ID
- BF 13.1.2021:51
- Conditions
- Clinical Pregnancy, Embryo Implantation
- Keywords
- DNA, amplification, blastocyst fluid, blastocyst selection, frozen embryo transfer, minimally invasive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for the trial was cancelled by funding organization
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Antalya IVFUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 9 Feb 2021 (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.
Introduction: Although innovative procedural changes in frozen embryo transfer (FET) cycles have increased the implantation rate of blastocysts transferred significantly, blastocyst selection remains a significant limiting factor in implantation outcomes. To improve implantation rates requires conventional microscopic blastocyst morphology scoring/selection technique to be replaced by an enhanced blastocyst selection technique or for the conventional morphology selection technique to be strengthened by novel supplementary selection techniques. Blastocoel fluid biopsy with DNA amplification is a minimally invasive (mi) technique that may supplement a blastocyst morphology score variables with a genetic variable.
Objective: In the present randomized controlled trial (RCT), DNA amplification in blastocoel fluid biopsies (BF-biopsy) will be investigated as a supplementary measure to select blastocysts for transfer in conjunction with blastocyst morphology scores. The objective will be to develop a minimally invasive blastocyst selection technique, which will improve selection and increase clinical implantations, while not increasing costs.
Materials and Methods: A single IVF centre double-blind randomised controlled trial, with patients recruited having female age 18 to 35 years from infertile patients presenting for freeze-all-IVF treatment. Enrolled patients (N = 500) with ≥five 2PN zygotes after ICSI will be randomised (1:1) to the two arms of the trial (i.e., test and control arm). In the test arm, 3 blastocysts will undergo blastocoel fluid biopsy (BF-biopsy) and whole-genomic amplification. Single blastocysts with no DNA amplification will be transferred in FETs of the test arm and single top-scoring blastocysts will be transferred in FETs of the control arm. The primary outcome measure of the trial will be clinical implantation (i.e., gestational sac with fetal heartbeat).
Results: The clinical implantation outcomes of FETs in which score-selected single blastocyst with no DNA amplification and score-selected single blastocysts were transferred will be compared.
Detailed description
Introduction The goal of assisted reproductive technology (ART) is the delivery of a healthy singleton, with the treatment strategy in IVF having the best chance being the transfer of the single most viable embryo from a patient's embryo cohort. Embryo selection, therefore, is paramount to the success of this goal. The microscopic assessment and scoring of embryo morphology was developed as an embryo selection technique in the early years of IVF (Veeck, 1991) and has ever since remained the most widely practised embryo selection technique. However, the technique's limited ability to maximise embryo implantation rates has for long been lamented and, therefore, more enhanced embryo selection techniques have for long been sought. Time-lapse monitoring and scoring (Paulson et al., 2018) and euploid embryo transfer using PGT-A (preimplantation genetic testing for aneuploidy; Gleicher et al., 2017) are recent innovations that have become contenders to replace conventional microscopic assessment and scoring of embryo morphology. An advantage of PGT-A is its independence of embryo development and morphological feature assessments, as euploid blastocysts implant at the same rate irrespective of blastocyst morphology score (Capalbo et al., 2014). Moreover, besides PGT-A's technical and biological limitations, the costs of implementation PGT-A as an embryo selection technique may be regarded prohibitive by many.
In the evolution of PGT in human IVF, PGT has progressed from PGT-v1 to PGT-v2 based on the adverse outcomes of biopsying 1-2 blastomeres from cleavage-stage embryos (PGT-v1) and the improvement in blastocyst development conditions. The evidence suggested that PGT-v.1 posed a significant risk to embryo viability, with no benefit resulting from the transfer of euploid embryos (Gleicher et al., 2017). The majority of studies have reported that PGT-v2, which requires the biopsying of 5-10 trophectoderm (TE) cells, poses no significant risk to the developmental potential (implantation viability) of biopsied blastocysts. However, recently there have been reports, suggesting that TE biopsy may not be completely free of risk (Gleicher et al., 2017, Ozgur et al., 2019). Currently, PGT-A faces four challenges preventing its routine use as a blastocyst selection technique; (1) the need for high technical expertise, (2) the invasiveness of TE biopsy, (3) the cost of the full technique, and (4) that TE biopsy is subject to sampling bias - a single TE biopsy of 5-10 cells may not accurately represent the ploidy of the whole blastocyst.
A spin-off of conventional PGT is the analysis of DNA in blastocoel fluid (BF). This phenomenon was first reported by Palini et al. (2013). The origin of the DNA in BF has been suggested to be the result of embryo euploidisation, i.e., the elimination of aneuploidy DNA or aneuploidic cells through regulatory processes such as apoptosis and or necrosis (Leaver and Wells, 2019). The practice of blastocyst collapse before vitrification (Mukaida et al., 2006, Iwayama et al., 2011) provides the opportunity to perform minimally invasive PGT-A (miPGT-A), i.e., the biopsying BF. In a study to investigate ploidy concordance between PGT-A with TE biopsy and PGT-A with BF biopsy, the authors found that the clinical pregnancy rate was 77% for blastocysts with no DNA amplification were transferred and 37% for blastocysts with DNA amplification (Magli et al., 2018). The mere accumulation of DNA in the BF, therefore, could be used as a supplementary measure to prioritise blastocysts for transfer. Implementing BF-biopsy and whole-genomic amplification (WGA) as a supplementary selection measure limits/reduces three of PGT-A's main challenges; (1) technical expertise, (2) invasiveness, and (3) costs.
In the present randomized controlled trial (RCT), the investigators will investigate DNA amplification in blastocyst fluid biopsies (BF-biopsy) as a supplementary selection technique to select blastocysts for transfer in conjunction with blastocyst morphology scores. The clinical implantation outcomes of FETs in which score-selected single blastocyst with no DNA amplification and score-selected single blastocysts were transferred will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A single IVF centre double-blind randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| DNA-amplification selection | Experimental | Procedure: blastocoel fluid biopsyIn the experimental arm, all blastocysts will undergo routine morphological assessment, with the 3 top-scoring blastocysts undergoing blastocoel fluid biopsy (BF-biopsy) and whole-genomic amplification. A single blastocyst with no DNA amplification will be selected for transfer in a frozen embryo transfer cycle. |
| Morfological-score selection | Active comparator | Procedure: blastocoel fluid biopsyIn the active comparator arm, all blastocysts will undergo routine morphological assessment. The (single) top-scoring blastocyst will be selected for transfer in a frozen embryo transfer cycle. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with female age 18≤35 years on the day of consultation (with the clinician projecting female age to be ≤35 on the day of oocyte retrieval).
- Patients who provide informed consent to participate in the trial and for the use of their anonymized data in research.
- Patients with ≤2 previous IVF treatments.
- Patients predicted to have single blastocyst transfers.
Key exclusion criteria (5 listed)
- Patients with female age >35 years on the day of consultation.
- Female patients with insulin-dependent diabetes or non-insulin-dependent diabetes mellitus and female patients with gastrointestinal, cardiovascular, pulmonary, liver or kidney disease.
- Female patients with any contraindications or allergies to the drugs used in routine freeze-all-IVF.
- Patients undergoing conventional PGT-A (aneuploidy) or PGT-M (monogenic disorders)
- Patients with less than 5 2-PN zygotes on day 1 of embryo development will be excluded from randomization.
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 |
|---|---|---|
| blastocoel fluid biopsyIn the present study, blastocoel fluid biopsy (BF-biopsy) and collapse will be performed using a microinjection pipette similar to that used to perform ICSI. The pipette will be pushed gently through the zona pellucida and TE, and up to 90% of the BF will be aspirated. | Procedure or surgery | DNA-amplification selection, Morfological-score selection |
Primary outcome
clinical implantation
Time frame: Transvaginal ultrasound examinations will be performed after 5 weeks of gestation
Clinical implantation will be defined as a cycle with an ultrasound confirmed normal gestational sac and heartbeat.
2 secondary outcomes
pregnancy
Time frame: Blood serum pregnancy tests will be performed 9 days after blastocyst transfer
ongoing pregnancy
Time frame: Transvaginal ultrasound examinations will be performed after 12 weeks of gestation
Results and safety
The study was stopped early (reason given: Funding for the trial was cancelled by funding organization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 24578475Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26.
- Results publication: PubMed 21152966Iwayama H, Hochi S, Yamashita M. In vitro and in vivo viability of human blastocysts collapsed by laser pulse or osmotic shock prior to vitrification. J Assist Reprod Genet. 2011 Apr;28(4):355-61. doi: 10.1007/s10815-010-9522-4. Epub 2010 Dec 9.
- Results publication: PubMed 30528055Magli MC, Albanese C, Crippa A, Tabanelli C, Ferraretti AP, Gianaroli L. Deoxyribonucleic acid detection in blastocoelic fluid: a new predictor of embryo ploidy and viable pregnancy. Fertil Steril. 2019 Jan;111(1):77-85. doi: 10.1016/j.fertnstert.2018.09.016. Epub 2018 Dec 5.
- Results publication: PubMed 30617927Ozgur K, Berkkanoglu M, Bulut H, Yoruk GDA, Candurmaz NN, Coetzee K. Single best euploid versus single best unknown-ploidy blastocyst frozen embryo transfers: a randomized controlled trial. J Assist Reprod Genet. 2019 Apr;36(4):629-636. doi: 10.1007/s10815-018-01399-1. Epub 2019 Jan 7.
- Results publication: PubMed 23557766Palini S, Galluzzi L, De Stefani S, Bianchi M, Wells D, Magnani M, Bulletti C. Genomic DNA in human blastocoele fluid. Reprod Biomed Online. 2013 Jun;26(6):603-10. doi: 10.1016/j.rbmo.2013.02.012. Epub 2013 Mar 13.
- Results publicationVeeck LL: Atlas of the Human Oocytes and Early Conceptus. 1991, Vol. 2. Baltimore, Williams & Willkins Co.
- Results publication: PubMed 29653705Paulson RJ, Reichman DE, Zaninovic N, Goodman LR, Racowsky C. Time-lapse imaging: clearly useful to both laboratory personnel and patient outcomes versus just because we can doesn't mean we should. Fertil Steril. 2018 Apr;109(4):584-591. doi: 10.1016/j.fertnstert.2018.01.042. No abstract available.
- Results publication: PubMed 28449669Gleicher N, Metzger J, Croft G, Kushnir VA, Albertini DF, Barad DH. A single trophectoderm biopsy at blastocyst stage is mathematically unable to determine embryo ploidy accurately enough for clinical use. Reprod Biol Endocrinol. 2017 Apr 27;15(1):33. doi: 10.1186/s12958-017-0251-8.
- Results publication: PubMed 16936299Mukaida T, Oka C, Goto T, Takahashi K. Artificial shrinkage of blastocoeles using either a micro-needle or a laser pulse prior to the cooling steps of vitrification improves survival rate and pregnancy outcome of vitrified human blastocysts. Hum Reprod. 2006 Dec;21(12):3246-52. doi: 10.1093/humrep/del285. Epub 2006 Aug 26.
- Individual participant dataSharing planned: Yes. The IPD plan sharing plan: The protocol will be published (word document) on the completion of registration on ClinicalTrials.gov The relevant clinical data will be published on journal acceptance of the study (excel spreadsheet)
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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.
Kemal Ozgur, MD study director
Antalya IVF
Kevin Coetzee, PhD principal investigator
Antalya IVF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blastocoel fluid biopsy in people with Clinical Pregnancy and Embryo Implantation, run by Antalya IVF at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 20 Feb 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 Turkey (Türkiye). 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: Funding for the trial was cancelled by funding organization). 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 implantation (time frame: Transvaginal ultrasound examinations will be performed after 5 weeks of gestation). 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 NCT04744844, which also lists 9 linked publications.
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 20 Feb 2024.