Clinical trial NCT03354013: Genetic Screening and Assisted Oocyte Activation in Couples with Diminished/aberrant Embryonic Development.
Official title: Genetic Screening and Investigating the Effect of Assisted Oocyte Activation in Couples with Diminished/aberrant Embryonic Development.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo
Embryo Disorder
Genetic Disease
Keywords: AOA
embryo developmental problems
genetic screening
calcium pattern analysis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Blastocyst rate
timeFrame: 5 days after oocyte retrieval
Secondary outcomes:
measure: Pregnancy rate
timeFrame: Positive hCG 16 days after oocyte retrieval
measure: Live birth rate
timeFrame: 37 - 42 weeks after last menstruation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Flandres
Study officials:
affiliation: University Ghent
name: Petra De Sutter, M.D; PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Björn Heindryckx, Prof.; PhD
role: PRINCIPAL_INVESTIGATOR
References: