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Comparison of IVF and ICSI in Human IVF

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
ICSI
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring in vitro fertilization, intracytoplasmic sperm injection, fertilization, Assisted reproduction

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Semmelweis University First Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IVF

ICSI

Arm Description

Oocytes fertilized by conventional in vitro fertilization (IVF) method

Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method

Outcomes

Primary Outcome Measures

Fertilization rate
Number of oocytes fertilized

Secondary Outcome Measures

Embryo quality
Number and quality of blastomeres, amount of fragmentation, embryo grade
Implantation rate
Number of embryos implanted (/number of embryos transferred)
Clinical pregnancy rate
Number of clinical pregnancies (/No. of embryo transfers)

Full Information

First Posted
March 26, 2018
Last Updated
April 19, 2018
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT03513913
Brief Title
Comparison of IVF and ICSI in Human IVF
Official Title
Comparison of the Effect of Conventional IVF and ICSI Fertilization Method on Human IVF Treatment Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
in vitro fertilization, intracytoplasmic sperm injection, fertilization, Assisted reproduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVF
Arm Type
Experimental
Arm Description
Oocytes fertilized by conventional in vitro fertilization (IVF) method
Arm Title
ICSI
Arm Type
Experimental
Arm Description
Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method
Intervention Type
Procedure
Intervention Name(s)
ICSI
Intervention Description
Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
Primary Outcome Measure Information:
Title
Fertilization rate
Description
Number of oocytes fertilized
Time Frame
18 hours after insemination
Secondary Outcome Measure Information:
Title
Embryo quality
Description
Number and quality of blastomeres, amount of fragmentation, embryo grade
Time Frame
36 and 72 hours after fertilization
Title
Implantation rate
Description
Number of embryos implanted (/number of embryos transferred)
Time Frame
4 weeks after embryo transfer
Title
Clinical pregnancy rate
Description
Number of clinical pregnancies (/No. of embryo transfers)
Time Frame
4 weeks after the embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Fancsovits, PhD
Phone
+36208250520
Email
fancsovits.peter@noi1.sote.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Janos Urbancsek, DSc
Phone
+3612660115
Email
urbancsek.janos@noi1.sote.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Fancsovits, PhD
Organizational Affiliation
Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Janos Urbancsek, DSc
Organizational Affiliation
Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Csaba Pribenszky, PhD
Organizational Affiliation
University of Veterinary Science, Budapest, Hungary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Lehner, PhD
Organizational Affiliation
Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zita Kaszás, BSc
Organizational Affiliation
Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miklós I Ács, MD
Organizational Affiliation
Klinikum Kempten Oberallgäu, Kempten, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University First Department of Obstetrics and Gynecology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Fancsovits, Ph.D.
Phone
+36309821382
Email
fancsovits.peter@noi1.sote.hu
First Name & Middle Initial & Last Name & Degree
Janos Urbancsek, DSc
Phone
+3612660115
Email
urbancsek.janos@noi1.sote.hu

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of IVF and ICSI in Human IVF

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