NCT03561129

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

20 years

First QC Date

June 7, 2018

Last Update Submit

June 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate per operator

    number of viable intrauterine embryos/ total number of embryos transferred per operator

    20 years

Interventions

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

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • cryo thawed embryos' transfers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21075368BACKGROUND
  • 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.

    PMID: 11870120BACKGROUND
  • 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.

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 19, 2018

Study Start

January 1, 1997

Primary Completion

December 31, 2016

Study Completion

December 31, 2017

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share