Comparison of IVF and ICSI in Human IVF

Infertility Clinical Trial

Official title:

Comparison of the Effect of Conventional IVF and ICSI Fertilization Method on Human IVF Treatment Outcome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03513913
• Other study ID #: SemmelweisU-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2018
• Source: Semmelweis University
• Contact: Peter Fancsovits, PhD
• Phone: +36208250520
• Email: fancsovits.peter[@]noi1.sote.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• ICSI
Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)

Locations

Country	Name	City	State
Hungary	Semmelweis University First Department of Obstetrics and Gynecology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	Number of oocytes fertilized	18 hours after insemination
Secondary	Embryo quality	Number and quality of blastomeres, amount of fragmentation, embryo grade	36 and 72 hours after fertilization
Secondary	Implantation rate	Number of embryos implanted (/number of embryos transferred)	4 weeks after embryo transfer
Secondary	Clinical pregnancy rate	Number of clinical pregnancies (/No. of embryo transfers)	4 weeks after the embryo transfer