Genetic Screening and Assisted Oocyte Activation in Couples With Diminished/Aberrant Embryonic Development. (AOA)
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|ClinicalTrials.gov Identifier: NCT03354013|
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : November 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Embryo Embryo Disorder Genetic Disease||Procedure: AOA Diagnostic Test: Genetic screening Diagnostic Test: Calcium pattern analysis||Not Applicable|
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. If less than 6 mature oocytes are collected, ICSI-AOA will be applied to all oocytes. Regardless of the treatment group (ICSI or ICSI-AOA), 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 in the PLCzeta gene (male), the DUX4 gene (male and female) and possible other genes which are involved in and necessary in the early steps of oocyte activation and embryo development (such as DUX4 gene, PADI6 gene,...).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genetic Screening and Investigating the Effect of Assisted Oocyte Activation in Couples With Diminished/Aberrant Embryonic Development.|
|Estimated Study Start Date :||November 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: AOA, genetic screening, calcium pattern
Clinical setting: Patients will undergo 100% ICSI-AOA if less than 6 mature oocytes are collected upon oocyte retrieval. If 6 or more mature oocytes are retrieved, 50%ICSI and 50%ICSI-AOA will be applied.
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.
100% ICSI-AOA will be performed in the group with less than 6 mature oocytes; 50% ICSI/50% ICSI-AOA will be performed when 6 or more mature oocytes are retrieved
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.
Diagnostic Test: 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.
- 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.
- 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
- Live birth rate [ Time Frame: 37 - 42 weeks after last menstruation ]Pregnant women will be followed up. Live births will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354013
|Contact: Davina Bonte, MSc||+32 (0)93324218 +32(0)93324219||Davina.Bonte@UGent.be|
|Contact: Sara Somers, MSc||+32 (0)9 332 37 firstname.lastname@example.org|
|Principal Investigator:||Petra De Sutter, M.D; PhD||University Ghent|
|Principal Investigator:||Björn Heindryckx, Prof.; PhD||University Hospital, Ghent|