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Comparison of IVF and ICSI in Human IVF

NCT ID: NCT03513913

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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IVF

Oocytes fertilized by conventional in vitro fertilization (IVF) method

Group Type EXPERIMENTAL

ICSI

Intervention Type PROCEDURE

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

ICSI

Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method

Group Type EXPERIMENTAL

ICSI

Intervention Type PROCEDURE

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

Interventions

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ICSI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Peter Fancsovits, Ph.D.

Senior cilincal embryologyst

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Fancsovits, PhD

Role: STUDY_CHAIR

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

Janos Urbancsek, DSc

Role: PRINCIPAL_INVESTIGATOR

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

Csaba Pribenszky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Veterinary Science, Budapest, Hungary

Adam Lehner, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Zita Kaszás, BSc

Role: PRINCIPAL_INVESTIGATOR

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

Miklós I Ács, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Kempten Oberallgäu, Kempten, Germany

Locations

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Semmelweis University First Department of Obstetrics and Gynecology

Budapest, , Hungary

Site Status

Countries

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Hungary

Central Contacts

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Peter Fancsovits, PhD

Role: CONTACT

[email protected]
+36208250520

Janos Urbancsek, DSc

Role: CONTACT

[email protected]
+3612660115

Facility Contacts

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Peter Fancsovits, Ph.D.

Role: primary

[email protected]
+36309821382

Janos Urbancsek, DSc

Role: backup

[email protected]
+3612660115

Other Identifiers

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SemmelweisU-003

Identifier Type: -

Identifier Source: org_study_id

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