InfertilityNCT03513913
Comparison of IVF and ICSI in Human IVF
A study testing ICSI in people with Infertility, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- ICSI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteHungary
- Study dates
- 30 Apr 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in <50% fertilization rate
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University First Department of Obstetrics and Gynecology
Budapest, 1088
Peter Fancsovits, Ph.D., +36309821382, fancsovits.peter@noi1.sote.hu
Janos Urbancsek, DSc, +3612660115, urbancsek.janos@noi1.sote.hu
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- ICSI
- Keywords
- in vitro fertilization, intracytoplasmic sperm injection, fertilization, Assisted reproduction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSIProcedure or surgery
Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
| Study group | Role | What they receive |
|---|---|---|
| IVF | Experimental | Oocytes fertilized by conventional in vitro fertilization (IVF) method Receives: Procedure: ICSI |
| ICSI | Experimental | Oocytes fertilized by intracytoplasmic sperm injection (ICSI) method Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Number of oocytes fertilized
Measured: 18 hours after insemination
Secondary outcomes (3)
Embryo quality
Number and quality of blastomeres, amount of fragmentation, embryo grade
Measured: 36 and 72 hours after fertilization
Implantation rate
Number of embryos implanted (/number of embryos transferred)
Measured: 4 weeks after embryo transfer
Clinical pregnancy rate
Number of clinical pregnancies (/No. of embryo transfers)
Measured: 4 weeks after the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start30 Apr 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Fancsovits, Ph.D., Semmelweis University
- Investigators
- Peter Fancsovits, PhD, Study chair, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, HungaryJanos Urbancsek, DSc, Principal investigator, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, HungaryCsaba Pribenszky, PhD, Principal investigator, University of Veterinary Science, Budapest, HungaryAdam Lehner, PhD, Principal investigator, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, HungaryZita Kaszás, BSc, Principal investigator, Semmelweis University First Department of Obstetrics and Gynecology, Budapest, HungaryMiklós I Ács, MD, Principal investigator, Klinikum Kempten Oberallgäu, Kempten, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513913
- Sponsor's protocol ID
- SemmelweisU-003
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Conventional IVF and ICSI Fertilization Method on Human IVF Treatment Outcome
- ClinicalTrials.gov ID
- NCT03513913
- Acronym / sponsor ID
- SemmelweisU-003
- Conditions
- Infertility
- Keywords
- in vitro fertilization, intracytoplasmic sperm injection, fertilization, Assisted reproduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 30 Apr 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF | Experimental | Procedure: ICSIOocytes fertilized by conventional in vitro fertilization (IVF) method |
| ICSI | Experimental | Procedure: ICSIOocytes fertilized by intracytoplasmic sperm injection (ICSI) method |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Samen sample is not suitable for conventional IVF fertilization Previous conventional IVF treatment resulted in <50% fertilization rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICSIOocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) | Procedure or surgery | ICSI, IVF |
Primary outcome
Fertilization rate
Time frame: 18 hours after insemination
Number of oocytes fertilized
3 secondary outcomes
Embryo quality
Time frame: 36 and 72 hours after fertilization
Implantation rate
Time frame: 4 weeks after embryo transfer
Clinical pregnancy rate
Time frame: 4 weeks after the embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Fancsovits, PhD study chair
Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
Janos Urbancsek, DSc principal investigator
Semmelweis University First Department of Obstetrics and Gynecology, Budapest, Hungary
Csaba Pribenszky, PhD principal investigator
University of Veterinary Science, Budapest, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSI in people with Infertility, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Fancsovits, PhD (+36208250520, fancsovits.peter@noi1.sote.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 18 hours after insemination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.