Genetic Screening and Assisted Oocyte Activation in Couples With Diminished/Aberrant Embryonic Development. (AOA)

May 24, 2023 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • East-Flandres
      • Ghent, East-Flandres, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AOA, genetic screening, calcium pattern

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: AOA
100% ICSI-AOA will be performed.
Diagnostic test: Genetic screening
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.
Diagnostic test: Calcium pattern analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst rate
Time Frame: 5 days after oocyte retrieval
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: Positive hCG 16 days after oocyte retrieval
The level of beta-hCG in serum will be checked 16 days after oocyte retrieval
Positive hCG 16 days after oocyte retrieval
Live birth rate
Time Frame: 37 - 42 weeks after last menstruation
Pregnant women will be followed up. Live births will be recorded.
37 - 42 weeks after last menstruation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Petra De Sutter, M.D; PhD, University Ghent
  • Principal Investigator: Björn Heindryckx, Prof.; PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

September 9, 2022

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201732853
  • 2017/0819 (Other Identifier: Commissie Medische Ethiek (UZ Gent))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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