Embryotransfer Operator and Pregnancy Rate

Completed

• Conditions: Sterility

• Registration Number: NCT03561129
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Several studies had analyzed the correlation between embryo transfer operator experience and implantation, clinical pregnancy, abortion and delivery rate.

The aim of the present study is determining if the probabilities of embryo implantation and pregnancy are associated to the operator performing the embryo transfer.

This study allows following more than 30 different operators in a global period of 20 years with almost 20,000 procedures.

Detailed Description

Several studies had analyzed the correlation between embryo transfer operator experience and implantation, clinical pregnancy, abortion and delivery rate. Until now, the evidences are mixed and inconclusive.

The aim of the present study is determining if the probabilities of embryo implantation and pregnancy are associated to the operator performing the embryo transfer.

The database includes all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles. Only embryo transfers performed by the surgeon on duty for that day ("Gynecologist of the Day") will be included.

Secondary end point is to evaluate if it is possible to draw a learning curve for transfer in terms of pregnancies for the different surgeons.

The strength of this study relies on the completeness of the preoperative factors and follow up and on the vastest dataset in literature that can permit to correct for multiple confounders and analyze a wide group of outcomes.

Study Timeline

• Study Start: 1997-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-06
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200000

Inclusion Criteria

• fresh embryos' transfers
• embryo transfers performed only by the surgeon on duty for that day ("Gynecologist of the Day")

Exclusion Criteria

• cryo thawed embryos' transfers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate per operator	20 years	number of viable intrauterine embryos/ total number of embryos transferred per operator