Embryotransfer Operator and Pregnancy Rate | NCT03561129

Studies
Embryotransfer Operator and Pregnancy Rate

NCT03561129

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Jun 20, 2018Actual

Enrollment

200,000Actual

Phase

Not provided

Conditions

Sterility

Interventions

Embryo transfer

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1997Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jun 7, 2018

First Submission Date that Met QC Criteria

Jun 18, 2018

First Posted Date

Jun 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2018

Last Update Posted Date

Jun 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embryo transfer	Other	all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles, divided per operator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy rate per operator	number of viable intrauterine embryos/ total number of embryos transferred per operator	20 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21075368	Background	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.
11870120	Background	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques