Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer

IVF Clinical Trial

Official title:

Pregnancy Rate in Single Step Versus After Load Technique of Embryo Transfer: a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364528
• Other study ID #: 12022
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8127
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• IVF procedure

• Fresh and frozen single blastocyst transfer

Exclusion Criteria:

• Any blastocysts that underwent PGS testing

• Embryos derived from gamete donation

• Embryos imported from other centers

Related Conditions & MeSH terms

• Embryo Transfer
• Fertility Issues
• Infertility
• IVF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 years