Clinical trial NCT03561129: Embryotransfer Operator and Pregnancy Rate
Official title: Does the Operator Performing the Embryo Transfer Significantly Influence the Cycle Outcome: A Retrospective Evaluation of Humanitas Fertility Center's Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sterility
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 200000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study 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. A wider similar database was used for a previous research.

Data are collected using an exclusive internal web-based database.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate per operator
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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. doi: 10.1093/humrep/17.3.666.
citation: Cirillo F, Patrizio P, Baccini M, Morenghi E, Ronchetti C, Cafaro L, Zannoni E, Baggiani A, Levi-Setti PE. The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome? Hum Reprod. 2020 Feb 29;35(2):275-282. doi: 10.1093/humrep/dez290.