Embryotransfer Operator and Pregnancy Rate

Sterility Clinical Trial

— Operator  

Official title:

Does the Operator Performing the Embryo Transfer Significantly Influence the Cycle Outcome: A Retrospective Evaluation of Humanitas Fertility Center's Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561129
• Other study ID #: XXX/2018
• Status: Completed
• Start date: January 1, 1997
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2018
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200000
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Sterility

Intervention

Other:
• Embryo transfer
all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles, divided per operator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (2)

Uyar A, Bener A, Ciray HN, Bahceci M. Physician experience in performing embryo transfers may affect outcome. Fertil Steril. 2011 Apr;95(5):1860-2. doi: 10.1016/j.fertnstert.2010.10.036. — View Citation

van Weering HG, Schats R, McDonnell J, Vink JM, Vermeiden JP, Hompes PG. The impact of the embryo transfer catheter on the pregnancy rate in IVF. Hum Reprod. 2002 Mar;17(3):666-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate per operator	number of viable intrauterine embryos/ total number of embryos transferred per operator	20 years