NCT05364528

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8,127

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

6 years

First QC Date

May 3, 2022

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 years

Secondary Outcomes (1)

  • difficult transfer rate

    6 years

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • IVF procedure
  • Fresh and frozen single blastocyst transfer

You may not qualify if:

  • Any blastocysts that underwent PGS testing
  • Embryos derived from gamete donation
  • Embryos imported from other centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 6, 2022

Study Start

January 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 24, 2022

Record last verified: 2022-05