Preimplantation DiagnosisNCT02902614
Side of Embryo Biopsy Interfering Implantation Potential
A study testing Vegetal Pole blastomer embryo and Animal Pole blastomer embryo in people with Preimplantation Diagnosis, run by Ahmad Mustafa Mohamed Metwalley at 2 sites in 2 countries.
Trial summary
Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preimplantation Diagnosis
- What is being tested?
- Vegetal Pole blastomer embryo and Animal Pole blastomer embryo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2015to 2 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- grade 1 or 2 embryos at eight cell stage or 8-1/ 8-2 embryo quality.
Who cannot join
- grade 3 embryo at day 3, or 8-3 embryos.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Embryo Biopsy Side on Post Biopsy Blastocyst Structurs and Implantation
Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT.
Read the detailed description
During process of embryo biopsy, it was indicated to avoid contacting cells closer to inner cell mass as it can decrease the quality of embryo and its structural composition. However, recommendation for collection from the trophectoderm (TE) side is indicated.
Absence of differentiation during cleavage-stage or morula stage at day 3 and day 4 respectively, will present the needful to focus a specific location for embryo biopsy during pre-blastocyst stages for embryo going to do genetic testing before implantation or embryo transfer.
In articulation around the second polar body or the animal pole of embryo, collection of the cell from the vegetal pole in crospondence to avoide collection form the animal pole is to be compare the results of implantation for biopsy done using the animal pole side or the random non organized biosy procedure.
- Conditions
- Preimplantation Diagnosis
- Being tested
- Vegetal Pole blastomer embryo, Animal Pole blastomer embryo
- Keywords
- embryo biopsy, preimplantation genetic testing, animal pole, vegetal pole, day 3 embryo biopsy, embryo implantation, Blastomeres
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetal Pole blastomer embryoProcedure or surgery
Also called Biopsy embryo from sides considered far from ICM location.
for day 3 embryo biopsy / cleavage stage
Animal Pole blastomer embryoProcedure or surgery
Also called Random biopsy without considering specific location
for day 3 embryo biopsy / cleavage stage
| Study group | Role | What they receive |
|---|---|---|
| Vegetal Pole blastomer embryo | Experimental | for day 3 embryo biopsy / cleavage stage: Blastomere collection from opposite side to the 2nd polar body or from vegetal pole. Receives: Procedure: Vegetal Pole blastomer embryo; Procedure: Animal Pole blastomer embryo |
| Animal Pole blastomer embryo | Experimental | for day 3 embryo biopsy / cleavage stage: Blastomere collection from and side around the 2nd polar body and not the vegetal pole. Receives: Procedure: Vegetal Pole blastomer embryo; Procedure: Animal Pole blastomer embryo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blastocyst location of ICM at day 5
describing the location of the inner cell mass (ICM) in location to the zona peluceda (ZP) drilling opening.
Measured: 2 months
Secondary outcomes (1)
Implantation power
calculating the pregnancy rate for cases after biopsy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJan 2015
- Primary completion1 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preimplantation DiagnosisStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Mustafa Mohamed Metwalley
- Sponsor type
- University, hospital or other
- Collaborators
- Ibn Sina Hospital
- Responsible party
- Sponsor-investigator, Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital
- Investigators
- Ahmad M Metwalley, Principal investigator, Al Baraka Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902614
- Sponsor's protocol ID
- Embryo Biopsy
- Status last verified
- Jan 2019
- First submitted
- 7 Sep 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After abstract submission or after final approval for scientific paper
Publications
Tscherne RJ, Capitano G. High-pressure liquid chromatographic separation of pharmaceutical compounds using a mobile phase containing silver nitrate. J Chromatogr. 1977 Jun 11;136(2):337-41. doi: 10.1016/s0021-9673(00)86290-1. No abstract available.
PubMed 195970Geraedts J, Sermon K. Preimplantation genetic screening 2.0: the theory. Mol Hum Reprod. 2016 Aug;22(8):839-44. doi: 10.1093/molehr/gaw033. Epub 2016 Jun 2.
PubMed 27256482Balakier H, Sojecki A, Motamedi G, Librach C. Impact of multinucleated blastomeres on embryo developmental competence, morphokinetics, and aneuploidy. Fertil Steril. 2016 Sep 1;106(3):608-614.e2. doi: 10.1016/j.fertnstert.2016.04.041. Epub 2016 May 18.
PubMed 27206619Cimadomo D, Capalbo A, Ubaldi FM, Scarica C, Palagiano A, Canipari R, Rienzi L. The Impact of Biopsy on Human Embryo Developmental Potential during Preimplantation Genetic Diagnosis. Biomed Res Int. 2016;2016:7193075. doi: 10.1155/2016/7193075. Epub 2016 Jan 28.
PubMed 26942198Wang Z, Ang WT, Tan SY, Latt WT. Automatic segmentation of zona pellucida and its application in cleavage-stage embryo biopsy position selection. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3859-64. doi: 10.1109/EMBC.2015.7319236.
PubMed 26737136Dahdouh EM, Balayla J, Audibert F; Genetics Committee; Wilson RD, Audibert F, Brock JA, Campagnolo C, Carroll J, Chong K, Gagnon A, Johnson JA, MacDonald W, Okun N, Pastuck M, Vallee-Pouliot K. RETIRED: Technical Update: Preimplantation Genetic Diagnosis and Screening. J Obstet Gynaecol Can. 2015 May;37(5):451-63. doi: 10.1016/s1701-2163(15)30261-9.
PubMed 26168107
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Embryo Biopsy Side on Post Biopsy Blastocyst Structurs and Implantation
- ClinicalTrials.gov ID
- NCT02902614
- Acronym / sponsor ID
- Embryo Biopsy
- Conditions
- Preimplantation Diagnosis
- Keywords
- embryo biopsy, preimplantation genetic testing, animal pole, vegetal pole, day 3 embryo biopsy, embryo implantation, Blastomeres
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ahmad Mustafa Mohamed MetwalleyUniversity, hospital or other
- Collaborators
- Ibn Sina Hospital
- Study start
- Jan 2015
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 16 Sep 2016 (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.
Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT.
Detailed description
During process of embryo biopsy, it was indicated to avoid contacting cells closer to inner cell mass as it can decrease the quality of embryo and its structural composition. However, recommendation for collection from the trophectoderm (TE) side is indicated.
Absence of differentiation during cleavage-stage or morula stage at day 3 and day 4 respectively, will present the needful to focus a specific location for embryo biopsy during pre-blastocyst stages for embryo going to do genetic testing before implantation or embryo transfer.
In articulation around the second polar body or the animal pole of embryo, collection of the cell from the vegetal pole in crospondence to avoide collection form the animal pole is to be compare the results of implantation for biopsy done using the animal pole side or the random non organized biosy procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegetal Pole blastomer embryo | Experimental | Procedure: Vegetal Pole blastomer embryo, Procedure: Animal Pole blastomer embryofor day 3 embryo biopsy / cleavage stage: Blastomere collection from opposite side to the 2nd polar body or from vegetal pole. |
| Animal Pole blastomer embryo | Experimental | Procedure: Vegetal Pole blastomer embryo, Procedure: Animal Pole blastomer embryofor day 3 embryo biopsy / cleavage stage: Blastomere collection from and side around the 2nd polar body and not the vegetal pole. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- grade 1 or 2 embryos at eight cell stage or 8-1/ 8-2 embryo quality.
Key exclusion criteria (1 listed)
- grade 3 embryo at day 3, or 8-3 embryos.
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 |
|---|---|---|
| Vegetal Pole blastomer embryoAlso: Biopsy embryo from sides considered far from ICM location.for day 3 embryo biopsy / cleavage stage | Procedure or surgery | Animal Pole blastomer embryo, Vegetal Pole blastomer embryo |
| Animal Pole blastomer embryoAlso: Random biopsy without considering specific locationfor day 3 embryo biopsy / cleavage stage | Procedure or surgery | Animal Pole blastomer embryo, Vegetal Pole blastomer embryo |
Primary outcome
blastocyst location of ICM at day 5
Time frame: 2 months
describing the location of the inner cell mass (ICM) in location to the zona peluceda (ZP) drilling opening.
1 secondary outcome
Implantation power
Time frame: 2 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 15 Jan 2019.
- Results publication: PubMed 195970Tscherne RJ, Capitano G. High-pressure liquid chromatographic separation of pharmaceutical compounds using a mobile phase containing silver nitrate. J Chromatogr. 1977 Jun 11;136(2):337-41. doi: 10.1016/s0021-9673(00)86290-1. No abstract available.
- Results publication: PubMed 27256482Geraedts J, Sermon K. Preimplantation genetic screening 2.0: the theory. Mol Hum Reprod. 2016 Aug;22(8):839-44. doi: 10.1093/molehr/gaw033. Epub 2016 Jun 2.
- Results publication: PubMed 27206619Balakier H, Sojecki A, Motamedi G, Librach C. Impact of multinucleated blastomeres on embryo developmental competence, morphokinetics, and aneuploidy. Fertil Steril. 2016 Sep 1;106(3):608-614.e2. doi: 10.1016/j.fertnstert.2016.04.041. Epub 2016 May 18.
- Results publication: PubMed 26942198Cimadomo D, Capalbo A, Ubaldi FM, Scarica C, Palagiano A, Canipari R, Rienzi L. The Impact of Biopsy on Human Embryo Developmental Potential during Preimplantation Genetic Diagnosis. Biomed Res Int. 2016;2016:7193075. doi: 10.1155/2016/7193075. Epub 2016 Jan 28.
- Results publication: PubMed 26737136Wang Z, Ang WT, Tan SY, Latt WT. Automatic segmentation of zona pellucida and its application in cleavage-stage embryo biopsy position selection. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3859-64. doi: 10.1109/EMBC.2015.7319236.
- Results publication: PubMed 26168107Dahdouh EM, Balayla J, Audibert F; Genetics Committee; Wilson RD, Audibert F, Brock JA, Campagnolo C, Carroll J, Chong K, Gagnon A, Johnson JA, MacDonald W, Okun N, Pastuck M, Vallee-Pouliot K. RETIRED: Technical Update: Preimplantation Genetic Diagnosis and Screening. J Obstet Gynaecol Can. 2015 May;37(5):451-63. doi: 10.1016/s1701-2163(15)30261-9.
- Oct4 and Sox2 Directly Regulate Expression of Another Pluripotency Transcription Factor, Zfp206, in Embryonic Stem CellsLink provided by the sponsor.
- Oct4/Sox2 Binding Sites Contribute to Maintaining Hypomethylation of the Maternal Igf2/H19 Imprinting Control RegionLink provided by the sponsor.
- Formation of Pluripotent Stem Cells in the Mammalian Embryo Depends on the POU Transcription Factor Oct4Link provided by the sponsor.
- Multipotent cell lineages in early mouse development depend on SOX2 functionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After abstract submission or after final approval for scientific paper
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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.
Ahmad M Metwalley principal investigator
Al Baraka Fertility Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetal Pole blastomer embryo and Animal Pole blastomer embryo in people with Preimplantation Diagnosis, run by Ahmad Mustafa Mohamed Metwalley at 2 sites in 2 countries.
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 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bahrain, Egypt. 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?
blastocyst location of ICM at day 5 (time frame: 2 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 NCT02902614, which also lists 6 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 15 Jan 2019.