NCT02358759

Brief Summary

In this newly developed protocol, and idea, is to manage those abnormally developed zygotes from different ART procedures. The investigators developed the plan and requirements needed to select the target extra nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing healthy normal embryo.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

January 15, 2015

Last Update Submit

January 11, 2016

Conditions

Infertility

Keywords

Abnormal zygote fertilization3PNs correctionGiant oocyte managementtriploidy fertilizationMaternal nucleus removal

Outcome Measures

Primary Outcomes (1)

  • Normal Embryos Developed

    At 18 hours after ICSi nucleus to be removed in-order to make genetic correction for abnormally developed embryos. Final result is normal embryos produced with 2PNs evaluated by FSIH study for 5 chromosomes. This indicated the genetic correction process was successful process, and applicable to produce normal growing embryos.

    Day 1 or 18 hours post ICSI nucleus removal

Secondary Outcomes (2)

  • Day 3 embryo available for blastomer biopsy

    1 Year

  • 5 chromosomes FISH study

    1 Year

Other Outcomes (1)

  • Blastocyst development

    Day 5 embryo development for blastocyst stage

Study Arms (2)

Giant Oocytes after ICSI

ACTIVE COMPARATOR

abnormally produced oocyte after ART or Controlled ovarian stimulation. Correction of abnormally fertilized oocytes using nucleus removal.

Procedure: Correction of abnormally fertilized oocytes

3PNs zygotes developed after ICSI

ACTIVE COMPARATOR

Abnormally developed embryos these produced 3PNs. Correction of abnormally fertilized oocytes using nucleus removal.

Procedure: Correction of abnormally fertilized oocytes

Interventions

Correction of abnormally fertilized oocytesPROCEDURE

Removing of extra developed nucleus from fertilized oocyte.

3PNs zygotes developed after ICSIGiant Oocytes after ICSI

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Giant oocytes
  • PNs developed embryos at day 1 post ICSI.

You may not qualify if:

  • Patient refused to involving their abnormal oocytes at our study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al Baraka Fertility Hospital

Manama, Adliyah, 15006, Bahrain

Location

Ibn Sina IVF Center- Ibn Sina Hospital

Sohag, Sohag Governorate, 15006, Egypt

Location

Related Publications (5)

  • Jacobs PA, Angell RR, Buchanan IM, Hassold TJ, Matsuyama AM, Manuel B. The origin of human triploids. Ann Hum Genet. 1978 Jul;42(1):49-57. doi: 10.1111/j.1469-1809.1978.tb00930.x.

    PMID: 686684RESULT

  • Rosenbusch B. The potential significance of binovular follicles and binucleate giant oocytes for the development of genetic abnormalities. J Genet. 2012;91(3):397-404. doi: 10.1007/s12041-012-0195-x.

    PMID: 23271027RESULT

  • Wolf DP, Mitalipov N, Mitalipov S. Mitochondrial replacement therapy in reproductive medicine. Trends Mol Med. 2015 Feb;21(2):68-76. doi: 10.1016/j.molmed.2014.12.001. Epub 2014 Dec 10.

    PMID: 25573721RESULT

  • Vogel G. Assisted reproduction. FDA considers trials of 'three-parent embryos'. Science. 2014 Feb 21;343(6173):827-8. doi: 10.1126/science.343.6173.827. No abstract available.

    PMID: 24558137RESULT

  • Amato P, Tachibana M, Sparman M, Mitalipov S. Three-parent in vitro fertilization: gene replacement for the prevention of inherited mitochondrial diseases. Fertil Steril. 2014 Jan;101(1):31-5. doi: 10.1016/j.fertnstert.2013.11.030.

    PMID: 24382342RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmad M Metwalley

    Al Baraka Fertility Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
IVF unit director

Study Record Dates

First Submitted

January 15, 2015

First Posted

February 9, 2015

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

BA(1)EG(1)