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

Not Applicable

Completed

• Conditions: Embryo; Embryo Disorder; Genetic Disease
• Interventions: Procedure: AOA; Diagnostic Test: Genetic screening; Diagnostic Test: Calcium pattern analysis

• Registration Number: NCT03354013
• Lead Sponsor: University Hospital, Ghent

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.

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 Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Study Start: 2018-01-15
• Primary Completion: 2021-01-31
• Study Completion: 2022-09-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AOA, genetic screening, calcium pattern	Calcium pattern analysis	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.
AOA, genetic screening, calcium pattern	Genetic screening	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.
AOA, genetic screening, calcium pattern	AOA	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.

Primary Outcome Measures

Name	Time	Method
Blastocyst rate	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

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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, East-Flandres, Belgium