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

Genetic Disease Clinical Trial

— AOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354013
• Other study ID #: B670201732853
• Secondary ID: 2017/0819
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: September 9, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 9, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embryo
• Embryo Disorder
• Genetic Disease
• Genetic Diseases, Inborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East-Flandres

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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