Pregnancy Rate in Direct Versus Afterload Technique of Embryo Transfer

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.

Study Overview

• Status: Completed
• Conditions: Fertility Issues; IVF; Embryo Transfer

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 Type: Observational
• Enrollment (Actual): 8127

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 12022 (DAIDS-ES Registry Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No