Comparison of IVF and ICSI in Human IVF

Not Applicable

• Conditions: Infertility
• Interventions: Procedure: ICSI

• Registration Number: NCT03513913
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Study Start: 2018-04-30
• Study First Posted: 2018-05-02
• Last Update Posted: 2018-05-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVF	ICSI	Oocytes fertilized by conventional in vitro fertilization (IVF) method
ICSI	ICSI	Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method

Primary Outcome Measures

Name	Time	Method
Fertilization rate	18 hours after insemination	Number of oocytes fertilized

Secondary Outcome Measures

Name	Time	Method
Implantation rate	4 weeks after embryo transfer	Number of embryos implanted (/number of embryos transferred)
Clinical pregnancy rate	4 weeks after the embryo transfer	Number of clinical pregnancies (/No. of embryo transfers)
Embryo quality	36 and 72 hours after fertilization	Number and quality of blastomeres, amount of fragmentation, embryo grade

Trial Locations

Locations (1)

Semmelweis University First Department of Obstetrics and Gynecology; 🇭🇺 Budapest, Hungary