NCT02902614

Brief Summary

Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

September 7, 2016

Last Update Submit

January 12, 2019

Conditions

Preimplantation Diagnosis

Keywords

embryo biopsypreimplantation genetic testinganimal polevegetal poleday 3 embryo biopsyembryo implantationBlastomeres

Outcome Measures

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.

    2 months

Secondary Outcomes (1)

  • Implantation power

    2 months

Study Arms (2)

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.

Procedure: Vegetal Pole blastomer embryoProcedure: 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.

Procedure: Vegetal Pole blastomer embryoProcedure: Animal Pole blastomer embryo

Interventions

Vegetal Pole blastomer embryoPROCEDURE

for day 3 embryo biopsy / cleavage stage

Also known as: Biopsy embryo from sides considered far from ICM location.
Animal Pole blastomer embryoVegetal Pole blastomer embryo
Animal Pole blastomer embryoPROCEDURE

for day 3 embryo biopsy / cleavage stage

Also known as: Random biopsy without considering specific location
Animal Pole blastomer embryoVegetal Pole blastomer embryo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AHMAD Barakat

Manama, 15006, Bahrain

Location

Ibn Sina IVF Center- Ibn Sina Hospital

Sohag, 15006, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 195970RESULT

  • 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.

    PMID: 27256482RESULT

  • 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.

    PMID: 27206619RESULT

  • 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.

    PMID: 26942198RESULT

  • 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.

    PMID: 26737136RESULT

  • 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.

    PMID: 26168107RESULT

Related Links

Study Officials

  • Ahmad M Metwalley

    Al Baraka Fertility Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
IVF laboratory manager

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 16, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 2, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

After abstract submission or after final approval for scientific paper

Locations

BA(1)EG(1)