Fertility IssuesNCT05364528
Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer
An observational study of Fertility Issues and IVF, run by Istituto Clinico Humanitas.
Trial summary
The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques. The secondary end points include the evaluation of the difficult transfer rates. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Fertility Issues, IVF, Embryo Transfer
- How many people
- 8,127 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2021
- Phase
- Observational
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.
Who may be able to join
- IVF procedure
- Fresh and frozen single blastocyst transfer
Who cannot join
- Any blastocysts that underwent PGS testing
- Embryos derived from gamete donation
- Embryos imported from other centers
About this study
Official title: Pregnancy Rate in Single Step Versus After Load Technique of Embryo Transfer: a Retrospective Analysis
The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques.
The secondary end points include the evaluation of the difficult transfer rates.
Read the detailed description
The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.
Any blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers.
Data are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and IVF cycle.
- Conditions
- Fertility Issues, IVF, Embryo Transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| clinical pregnancies with direct catheter | Clinical pregnancies occurred after fresh and frozen blastocyst transfers using direct technique. | |
| clinical pregnancies with afterload catheter | Clinical pregnancies occurred after fresh and frozen blastocyst transfers using afterload technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
number of pregnancies diagnosed by ultrasonographic visualization of one or more gestational sacs x 100 divided by the number of embryo transfer cycles
Measured: 6 years
Secondary outcomes (1)
difficult transfer rate
advancement of the outer sheath, multiple attempts, force, required manipulation, use of a stylet or tenaculum, dilatation, use of a different catheter
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364528
- Sponsor's protocol ID
- 12022
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cirillo F, Immediata V, Ronchetti C, Carletti T, Morenghi E, Albani E, Baggiani A, Levi-Setti PE. Steps forward in embryo transfer technique: a retrospective study comparing direct versus afterload catheters at different time frames. J Assist Reprod Genet. 2023 Dec;40(12):2895-2902. doi: 10.1007/s10815-023-02957-y. Epub 2023 Oct 11.
PubMed 37819552
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Rate in Single Step Versus After Load Technique of Embryo Transfer: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05364528
- Acronym / sponsor ID
- 12022
- Conditions
- Fertility Issues, IVF, Embryo Transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,127 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 May 2022 (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.
The primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (ET) techniques.
The secondary end points include the evaluation of the difficult transfer rates.
Detailed description
The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.
Any blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers.
Data are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and IVF cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical pregnancies with direct catheter | – | –Clinical pregnancies occurred after fresh and frozen blastocyst transfers using direct technique. |
| clinical pregnancies with afterload catheter | – | –Clinical pregnancies occurred after fresh and frozen blastocyst transfers using afterload technique. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study database includes all the single fresh and frozen (G5-G6) blastocyst transfers performed at Humanitas Fertility Centre between 1st January 2016 and 31th December 2021 by using the direct and afterload protocols.
Key inclusion criteria (2 listed)
- IVF procedure
- Fresh and frozen single blastocyst transfer
Key exclusion criteria (3 listed)
- Any blastocysts that underwent PGS testing
- Embryos derived from gamete donation
- Embryos imported from other centers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical pregnancy rate
Time frame: 6 years
number of pregnancies diagnosed by ultrasonographic visualization of one or more gestational sacs x 100 divided by the number of embryo transfer cycles
1 secondary outcome
difficult transfer rate
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 37819552Cirillo F, Immediata V, Ronchetti C, Carletti T, Morenghi E, Albani E, Baggiani A, Levi-Setti PE. Steps forward in embryo transfer technique: a retrospective study comparing direct versus afterload catheters at different time frames. J Assist Reprod Genet. 2023 Dec;40(12):2895-2902. doi: 10.1007/s10815-023-02957-y. Epub 2023 Oct 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues and IVF, run by Istituto Clinico Humanitas.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364528, which also lists 1 linked publication.
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 24 May 2022.