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

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ClinicalTrials.gov Identifier: NCT03354013
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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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.

Condition or disease Intervention/treatment Phase
Embryo Embryo Disorder Genetic Disease Procedure: AOA Diagnostic Test: Genetic screening Diagnostic Test: Calcium pattern analysis Not Applicable

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. If less than 6 mature oocytes are collected, ICSI-AOA will be applied to all oocytes. Regardless of the treatment group (ICSI or ICSI-AOA), 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genetic Screening and Investigating the Effect of Assisted Oocyte Activation in Couples With Diminished/Aberrant Embryonic Development.
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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Arm Intervention/treatment
Experimental: AOA, genetic screening, calcium pattern

Clinical setting: Patients will undergo 100% ICSI-AOA if less than 6 mature oocytes are collected upon oocyte retrieval. If 6 or more mature oocytes are retrieved, 50%ICSI and 50%ICSI-AOA will be applied.

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 in the group with less than 6 mature oocytes; 50% ICSI/50% ICSI-AOA will be performed when 6 or more mature oocytes are retrieved

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Live birth rate [ Time Frame: 37 - 42 weeks after last menstruation ]
    Pregnant women will be followed up. Live births will be recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354013


Contacts
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Contact: Davina Bonte, MSc +32 (0)93324218 +32(0)93324219 Davina.Bonte@UGent.be
Contact: Sara Somers, MSc +32 (0)9 332 37 57 arg@uzgent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, East-Flandres, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Petra De Sutter, M.D; PhD University Ghent
Principal Investigator: Björn Heindryckx, Prof.; PhD University Hospital, Ghent
More Information
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03354013    
Other Study ID Numbers: B670201732853
2017/0819 ( Other Identifier: Commissie Medische Ethiek (UZ Gent) )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
AOA
embryo developmental problems
genetic screening
calcium pattern analysis
Additional relevant MeSH terms:
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Genetic Diseases, Inborn
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs