NCT03354013

Brief Summary

This is an interventional comparative study at the Department of Reproductive Medicine at Ghent University Hospital. Patients with previous embryo developmental problems are eligible for the study. Patients will undergo an ICSI-AOA treatment and will also be screened for genes important in the oocyte activation and embryonic development process. Also, the calcium releasing pattern of the patients' spermatozoa will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

November 21, 2017

Last Update Submit

September 5, 2024

Conditions

EmbryoEmbryo DisorderGenetic Disease

Keywords

AOAembryo developmental problemsgenetic screeningcalcium pattern analysis

Outcome Measures

Primary Outcomes (1)

  • Blastocyst rate

    Blastocyst rate will be calculated and blastocyst will be scored. The best quality embryos will be transferred and/or frozen.

    5 days after oocyte retrieval

Secondary Outcomes (2)

  • Pregnancy rate

    Positive hCG 16 days after oocyte retrieval

  • Live birth rate

    37 - 42 weeks after last menstruation

Study Arms (1)

AOA, genetic screening, calcium pattern

EXPERIMENTAL

Clinical setting: Patients will undergo ICSI-AOA. Furthermore, patients will give a saliva sample to do genetic screening. Genes important during oocyte activation and embryo development will be investigated. Also, calcium pattern analysis of the patients' spermatozoa will be executed.

Procedure: AOADiagnostic Test: Genetic screeningDiagnostic Test: Calcium pattern analysis

Interventions

AOAPROCEDURE

100% ICSI-AOA will be performed.

AOA, genetic screening, calcium pattern
Genetic screeningDIAGNOSTIC_TEST

Patients will donate a saliva sample. Genetic screening will take place for PLCzeta (male) and Dux4 (male and female). Also other possible genes involved in embryo development could be tested.

AOA, genetic screening, calcium pattern
Calcium pattern analysisDIAGNOSTIC_TEST

Male patients will donate a sperm sample. Calcium pattern analysis will take place by injecting the patients' sperm into mouse and/or human (in vitro matured) oocytes (research-donated control oocytes). This will estimate the sperm capability to induce calcium oscillations in the oocyte.

AOA, genetic screening, calcium pattern

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with one or more previous ICSI cycles (UZ Gent) AND
  • patients with:
  • complete developmental arrest (no transfer), or
  • complete developmental delay (no morula/blastocyst on Day 5), or
  • significantly reduced blastocyst formation (≤15%)
  • willing and able to give informed consent

You may not qualify if:

  • patients which went for oocyte or sperm donation
  • patients with severe male infertility or low fertilization (\<33%) after ICSI
  • cycles requiring surgical sperm recovery procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, East-Flandres, 9000, Belgium

Location

Related Publications (1)

  • Cardona Barberan A, Bonte D, Boel A, Thys V, Paredis R, Machtelinckx F, De Sutter P, De Croo I, Leybaert L, Stoop D, Coucke P, Vanden Meerschaut F, Heindryckx B. Assisted oocyte activation does not overcome recurrent embryo developmental problems. Hum Reprod. 2023 May 2;38(5):872-885. doi: 10.1093/humrep/dead051.

    PMID: 36931261DERIVED

MeSH Terms

Conditions

Genetic Diseases, Inborn

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Petra De Sutter, M.D; PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Björn Heindryckx, Prof.; PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

January 15, 2018

Primary Completion

January 31, 2021

Study Completion

September 9, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)