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AzTrials

EmbryoAOANCT03354013

Genetic Screening and Assisted Oocyte Activation in Couples with Diminished/aberrant Embryonic Development.

A study testing AOA, Genetic screening and Calcium pattern analysis in people with Embryo and Embryo Disorder, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Embryo, Embryo Disorder, Genetic Disease
What is being tested?
AOA, Genetic screening and Calcium pattern analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteBelgium
Study dates
15 Jan 2018to 9 Sep 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, East-Flandres, 9000

Other trials in Belgium

About this study

Official title: Genetic Screening and Investigating the Effect of Assisted Oocyte Activation in Couples with Diminished/aberrant Embryonic Development.

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.

Read the detailed description

Assisted Oocyte Activation (ICSI-AOA) will be the treatment for these patients to overcome their previous embryo developmental problems. This protocol artificially induces calcium rises in the oocyte, which mimics the natural oocyte activation process induced by the sperm factor PLCzeta. If 6 or more mature oocytes are collected at oocyte retrieval, 50%ICSI and 50% ICSI-AOA will be applied to all oocytes. The best embryo(s) will be transferred back. Rest embryo(s) will be vitrified for future cycles. Patients will be followed up.

Furthermore, an additional sperm sample will be produced to investigate the calcium inducing pattern of the patients' spermatozoa. Thereby, mouse and/or human (research-donated control oocytes) will be pre-incubated with a Ca2+ sensitive dye. Next, human spermatozoa will be injected into these mouse/human oocytes and the calcium pattern will be recorded under an inverted epifluorescence microscope.

Both partners will give a saliva sample to screen for mutations possible genes involved in oocyte activation and embryo development.

Being tested
AOA, Genetic screening, Calcium pattern analysis
Keywords
AOA, embryo developmental problems, genetic screening, calcium pattern analysis
Medical subject headings
Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AOAProcedure or surgery

    100% ICSI-AOA will be performed.

  • 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.

  • 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.

Study groups in NCT03354013
Study groupRoleWhat they receive
AOA, genetic screening, calcium patternExperimentalClinical 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.
Receives: Procedure: AOA; Diagnostic Test: Genetic screening; Diagnostic Test: Calcium pattern analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blastocyst rate

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

    Measured: 5 days after oocyte retrieval

Secondary outcomes (2)

  1. Pregnancy rate

    The level of beta-hCG in serum will be checked 16 days after oocyte retrieval

    Measured: Positive hCG 16 days after oocyte retrieval

  2. Live birth rate

    Pregnant women will be followed up. Live births will be recorded.

    Measured: 37 - 42 weeks after last menstruation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start15 Jan 2018
  3. Primary completion31 Jan 2021
  4. Study completion9 Sep 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03354013
Sponsor's protocol ID
B670201732853
Other IDs
2017/0819
Acronym
AOA
Status last verified
Sep 2024
First submitted
21 Nov 2017
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36931261

Questions about this trial

What is this clinical trial studying?

A study testing AOA, Genetic screening and Calcium pattern analysis in people with Embryo and Embryo Disorder, run by University Hospital, Ghent at 1 site in Belgium.

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 6 inclusion and 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 rate (time frame: 5 days after oocyte retrieval). 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 NCT03354013, which also lists 1 linked publication.

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 19 Sep 2024.

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