NCT03513913

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

3.7 years

First QC Date

March 26, 2018

Last Update Submit

April 19, 2018

Conditions

Infertility

Keywords

in vitro fertilizationintracytoplasmic sperm injectionfertilizationAssisted reproduction

Outcome Measures

Primary Outcomes (1)

  • Fertilization rate

    Number of oocytes fertilized

    18 hours after insemination

Secondary Outcomes (3)

  • Embryo quality

    36 and 72 hours after fertilization

  • Implantation rate

    4 weeks after embryo transfer

  • Clinical pregnancy rate

    4 weeks after the embryo transfer

Study Arms (2)

IVF

EXPERIMENTAL

Oocytes fertilized by conventional in vitro fertilization (IVF) method

Procedure: ICSI

ICSI

EXPERIMENTAL

Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method

Procedure: ICSI

Interventions

ICSIPROCEDURE

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

ICSIIVF

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in \<50% fertilization rate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University First Department of Obstetrics and Gynecology

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Peter Fancsovits, PhD

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

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Fancsovits, PhD

CONTACT

+36208250520fancsovits.peter@noi1.sote.hu

Janos Urbancsek, DSc

CONTACT

+3612660115urbancsek.janos@noi1.sote.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior cilincal embryologyst

Study Record Dates

First Submitted

March 26, 2018

First Posted

May 2, 2018

Study Start

April 30, 2018

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

May 2, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)