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NCT Number: NCT03354013

Genetic Screening and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, East-Flandres, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AOA

Procedure

100% ICSI-AOA will be performed.

Genetic Screening

Diagnostic 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 analysis

Diagnostic 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: AOA

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 27, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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