NCT03513913UnknownNot Applicable
Comparison of the Effect of Conventional IVF and ICSI Fertilization Method on Human IVF Treatment Outcome
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Semmelweis University
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Fertilization rate
Study Overview
Brief Summary
In this prospective randomized clinical trial we plan to compare two fertilization method which are widely used during in vitro fertilization (IVF) treatment. Outcome of conventional IVF and intracytoplasmic sperm injection (ICSI) treatment will be compared in this study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infertile patients entering in vitro fertilization treatment At least 1 oocytes collected Semen sample is suitable for IVF and ICSI fertilization as well Number of oocytes collected is lower than 5 AND/OR female age is equal or more than 40 years
Exclusion Criteria
- •Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in <50% fertilization rate
Arms & Interventions
IVF
Experimental
Oocytes fertilized by conventional in vitro fertilization (IVF) method
Intervention: ICSI (Procedure)
ICSI
Experimental
Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method
Intervention: ICSI (Procedure)
Outcomes
Primary Outcomes
Fertilization rate
Time Frame: 18 hours after insemination
Number of oocytes fertilized
Secondary Outcomes
- Implantation rate(4 weeks after embryo transfer)
- Clinical pregnancy rate(4 weeks after the embryo transfer)
- Embryo quality(36 and 72 hours after fertilization)
Investigators
Peter Fancsovits, Ph.D.
Senior cilincal embryologyst
Semmelweis University
Study Sites (2)
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