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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03354013
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 58.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Embryo; Embryo Disorder; Genetic Disease	Procedure: AOA; Diagnostic Test: Genetic screening; Diagnostic Test: Calcium pattern analysis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Genetic Screening and Investigating the Effect of Assisted Oocyte Activation in Couples With Diminished/Aberrant Embryonic Development.
• Actual Study Start Date: Jan 15, 2018
• Actual Primary Completion Date: Jan 31, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: AOA, genetic screening, calcium pattern 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.

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.; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Pregnancy rate [Positive hCG 16 days after oocyte retrieval]

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

2. Live birth rate [37 - 42 weeks after last menstruation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent	East-Flandres	Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Petra De Sutter, M.D; PhD, University Ghent
• Principal Investigator: Björn Heindryckx, Prof.; PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT03354013
• Other Study ID Numbers: B670201732853; 2017/0819
• First Posted: Nov 27, 2017
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Ghent: AOA; embryo developmental problems; genetic screening; calcium pattern analysis
• Additional relevant MeSH terms: Genetic Diseases, Inborn; Calcium

Study Results

No Results Posted as of Jul 21, 2022