The Impact of the Biologist Performing the Embryo Transfer on the Cycle Outcome

Infertility Clinical Trial

Official title:

Different Actors for the Same Play: the Impact of the Biologist Performing the Embryo Transfer on the Cycle Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827771
• Other study ID #: 2021-407
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective single center analysis which includes all the fresh, IOC (insemination of in vitro matured oocytes) and frozen embryo transfer (ET) performed between January 2000 and December 2019 at Humanitas Fertility Center after IVF-ICSI (In Vitro Fertilization - Intracytoplasmic Sperm Injection) cycles.

The primary objective is to determine the impact of the biologist performing the embryo transfer on the pregnancy probability, in terms of ongoing pregnancy rate (OPR), defined as the number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ET performed.

Secondary end point is to evaluate whether the biologists improve their performances as their experience increases, allowing the drawing of an ET learning curve in term of pregnancies for the different biologists.

The biologist's experience was assessed in terms of number of previous interventions performed prior to the day of ET. A total of 28 operators were eligible to participate in the study. Any biologists who performed less than 100 ETs was excluded from the analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion criteria:

Exclusion Criteria:

Any biologist who performed less than 100 embryo transfers was excluded from the analysis.

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (1)

Li H, Li L, Lu X, Sun X, Ng EHY. Comparison of the effect of immediate versus delayed transfer following a stimulated IVF cycle on the ongoing pregnancy rate of frozen-thawed embryo transfer cycles: a study protocol for a randomised controlled trial. BMJ Open. 2018 May 17;8(5):e020507. doi: 10.1136/bmjopen-2017-020507. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	The number of viable pregnancies that had completed at least 12 weeks of gestation per total ETs	20 years