ClinicalTrials.gg
CompletedNCT02902614Updated Jan 15, 2019

Side of Embryo Biopsy Interfering Implantation Potential

An interventional study of Vegetal Pole blastomer embryo and Animal Pole blastomer embryo in Preimplantation Diagnosis, sponsored by Ahmad Mustafa Mohamed Metwalley. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Ahmad Mustafa Mohamed Metwalley · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Preimplantation Diagnosis

Keywords

  • embryo biopsy
  • preimplantation genetic testing
  • animal pole
  • vegetal pole
  • day 3 embryo biopsy
  • embryo implantation
  • Blastomeres
03

In context

Lead sponsor

Ahmad Mustafa Mohamed Metwalley is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • grade 1 or 2 embryos at eight cell stage or 8-1/ 8-2 embryo quality.

Exclusion criteria

Exclusion Criteria:

  • grade 3 embryo at day 3, or 8-3 embryos.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Vegetal Pole blastomer embryo

    for day 3 embryo biopsy / cleavage stage: Blastomere collection from opposite side to the 2nd polar body or from vegetal pole.

    Procedure: Vegetal Pole blastomer embryo · Procedure: Animal Pole blastomer embryo

  • Experimental
    Animal Pole blastomer embryo

    for day 3 embryo biopsy / cleavage stage: Blastomere collection from and side around the 2nd polar body and not the vegetal pole.

    Procedure: Vegetal Pole blastomer embryo · Procedure: Animal Pole blastomer embryo

Interventions

  • ProcedureVegetal Pole blastomer embryo

    for day 3 embryo biopsy / cleavage stage

    Also known as: Biopsy embryo from sides considered far from ICM location.

  • ProcedureAnimal Pole blastomer embryo

    for day 3 embryo biopsy / cleavage stage

    Also known as: Random biopsy without considering specific location

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

Secondary outcomes

  1. Implantation power

    calculating the pregnancy rate for cases after biopsy.

    Time frame: 2 months

07

Study locations

2 sites
  • AHMAD Barakat
    Manama, 15006, Bahrain
  • Ibn Sina IVF Center- Ibn Sina Hospital
    Sohag, 15006, Egypt
08

References and documents

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 195970 ↗
  • Geraedts 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 27256482 ↗
  • Balakier 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 27206619 ↗
  • Cimadomo 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 26942198 ↗
  • Wang 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 26737136 ↗
  • Dahdouh 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 ↗

Individual participant data

Plan to share: Yes — After abstract submission or after final approval for scientific paper

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2016
First posted
Sep 16, 2016
Start
Jan 2015
Primary completionActual
Dec 1, 2018
CompletionActual
Dec 2, 2018
Last update
Jan 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02902614
Lead sponsor
Ahmad Mustafa Mohamed Metwalley
Collaborators
Ibn Sina Hospital
Responsible party
Ahmad Mustafa Mohamed Metwalley (IVF laboratory manager, Al Baraka Fertility Hospital) — Sponsor-investigator
First posted
Sep 16, 2016
Start date
Jan 2015
Primary completion
Dec 1, 2018
Completion
Dec 2, 2018
Last update
Jan 15, 2019

Study contacts

Ahmad M Metwalley
principal investigator · Al Baraka Fertility Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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