Comparison of IVF and ICSI in Human IVF

April 19, 2018 updated by: Peter Fancsovits, Ph.D., Semmelweis University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University First Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVF
Oocytes fertilized by conventional in vitro fertilization (IVF) method
Procedure: ICSI
Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
Experimental: ICSI
Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method
Procedure: ICSI
Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 18 hours after insemination
Number of oocytes fertilized
18 hours after insemination

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Study Chair: Peter Fancsovits, PhD, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
  • Principal Investigator: Janos Urbancsek, DSc, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
  • Principal Investigator: Csaba Pribenszky, PhD, University of Veterinary Science, Budapest, Hungary
  • Principal Investigator: Adam Lehner, PhD, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
  • Principal Investigator: Zita Kaszás, BSc, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
  • Principal Investigator: Miklós I Ács, MD, Klinikum Kempten Oberallgäu, Kempten, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SemmelweisU-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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