Genetic Screening and Assisted Oocyte Activation in Couples with Diminished/aberrant Embryonic Development.

University Hospital, Ghent42 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Embryo Embryo Disorder Genetic Disease

Interventions

AOAPROCEDURE

100% ICSI-AOA will be performed.

Genetic screeningDIAGNOSTIC_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 analysisDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ghent University Hospital

Ghent, East-Flandres, Belgium

Outcomes

Primary Outcomes

Blastocyst rate

Blastocyst rate will be calculated and blastocyst will be scored. The best quality embryos will be transferred and/or frozen.

Time frame: 5 days after oocyte retrieval

Secondary Outcomes

Pregnancy rate

The level of beta-hCG in serum will be checked 16 days after oocyte retrieval

Time frame: Positive hCG 16 days after oocyte retrieval

Live birth rate

Pregnant women will be followed up. Live births will be recorded.

Time frame: 37 - 42 weeks after last menstruation

Data from ClinicalTrials.gov

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